Quality Control, Quality Assurance & Microbiology

Quality Control & Quality Assurance

Quality Control is responsible for sample testing to fulfil the quality requirements of Health Canada, FDA and International Regulatory bodies. Quality Assurance ensures that production materials meet quality specifications and are compliant with regulatory guidelines through our planned and systematic quality systems. The primary purpose and mission of the department is to analyze the microbiological nature and make-up of substances, using a variety of modern microbiological techniques, methods and instrumentation for its customers in a highly efficient, cost effective and timely manner.

The Microbiology department is involved in work as diverse as microbiological analysis, quality control, environmental monitoring and trending, microbiological support activities for sterile manufacture, microbiological method development and validation as well as microbiological support for manufacturing process development as required.

We are always looking for new people to contribute to the company's growth. We offer a competitive salary and benefits and an excellent opportunity to build your career with a growing company. Thank you for your interest in working at Dalton Pharma. Please note that successful applicants will be notified by email within 2 weeks if they are selected for an interview. We do keep resumes on file. If we have an opening that better fits your career goals and experience, we will contact you.

Please forward your resume to:

Human Resources Department
Dalton Pharma Services Inc.
Email:

POSITIONS CURRENTLY AVAILABLE:

MICROBIOLOGY MANAGER

The Microbiology Manager, reporting to the Director of Quality, will be responsible for day-to day management of the Microbiology Laboratory and all microbiology testing at Dalton to ensure compliance with cGMP regulations, following internal, client and compendial methodologies. The incumbent will provide guidance for method development and validation, propose and implement improvements, and perform investigations for product and environmental monitoring excursions, while coordinating and prioritizing the laboratory workload to meet client requirements and turn-around time.

The successful candidate should meet the following qualifications and requirements.

Qualifications:
  • Strong knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile and non-sterile pharmaceutical products. Knowledge of the recently implemented Annex 1 and ability to perform a comprehensive gap analysis and implement actions to meet requirements.
  • Experience writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
  • Extensive experience performing testing for the enumeration and identification of microorganisms from raw materials, products, environment and utilities.
  • Extensive experience performing testing for the enumeration and identification of microorganisms from raw materials, products, environment, and utilities.
  • Extensive experience in conducting and/or reviewing microbial and/or endotoxin OOS investigations and the implementation of corrective actions and preventive actions (CAPAs) via change controls.
  • Responsibility for a Microbiology Laboratory to ensure timely completion of raw materials, in process testing and Drug Substance/Product release.
  • Performing routine record review and data analysis to identify trends. Update management on trends and implement corrective action plans when necessary.
  • Representing the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions.
  • Experience in coaching, mentoring, and training not only microbiologists but cross-functional team members in microbial principles and behaviour in environmentally controlled clean rooms.
  • Establishing a strong Microbiology presence in the organization by working closely with and assisting other teams to solve microbiology related issues.
  • Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.
Requirements:
  • A minimum Bachelor’s university degree in Microbiology. Preference will be given to candidates with an advanced degree.
  • 5+ years of experience as a Microbiology Manager, responsible for leading a team of microbiologists within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
  • 10+ years of practical and progressive experience in a microbiology related role in the pharmaceutical industry for commercial and clinical drug products.
  • Demonstrated experience in microbial and endotoxin testing of in-process & finished product, aseptic process simulations, environmental monitoring and testing of utilities (water, steam, etc).
  • Thorough knowledge of GMP, FDA, Health Canada and EU regulations and guidances, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
  • Experience with Annex 1 compliance & gap analysis
  • Excellent organizational skills and multi-tasking ability.
  • Excellent leadership, communication (written and verbal) and influencing skills.
  • Demonstrated ability to work in a team environment and build high-performing teams.
  • Proficient in the use of Microsoft software and Trackwise.

While we appreciate all applications received, only those selected for an interview will be contacted.

Job Types: Full-time, Permanent

Pay: From $80,000.00 per year

Benefits:
  • Casual dress
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Flexible schedule
  • Life insurance
  • RRSP match
  • Tuition reimbursement
  • Vision care
  • Wellness Program
Schedule:
  • 8 hour shift
Application question(s):
  • Are you comfortable with fully on-site work arrangement at our North York location?
  • Do you have experience with Annex 1 compliance & gap analysis?
Education:
  • Bachelor's Degree (preferred)
Experience:
  • Microbiology Manager: 5 years (preferred)
  • Nicrobiology (commercial & clinical drug products): 10 years (preferred)

Work Location: In person

CAPA Program Manager

The CAPA Program Manager, reporting to the Director of Quality, will oversee the company’s CAPA program. This role includes facilitating committee/review board meetings to ensure thorough investigations are conducted, root causes are identified, and appropriate SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) CAPAs are developed and implemented through change controls. This individual will serve as the subject matter expert (SME), providing training to cross-functional teams, and supporting client audits and regulatory inspections. Additionally, following up with relevant individuals and/or departments to ensure DEVs/LIRs, CAPAs, and CRs are completed/implemented within established timelines will be an essential function of this position.

The successful candidate should meet the following qualifications and requirements.

Experience Required
  • Proven experience working in a similar role in the pharmaceutical industry.
  • Extensive experience in conducting and/or reviewing laboratory, production (sterile and non-sterile), environment, and equipment/facility deviation investigations.
  • Demonstrated proficiency in utilizing problem-solving tools (such as Fishbone diagrams, 5 Whys, FMEA) to ensure thorough investigations that identify root causes, contributory factors, and systemic issues.
  • Experience in developing and/or assessing SMART CAPAs to ensure effective resolution of events and prevention of recurrence.
  • Implementing CAPAs through a change control program, ensuring changes do not negatively impact other parts of the quality system and remain compliant with company SOPs, client expectations, and regulatory requirements.
  • Leading steering committee/review meetings to guide event resolution and the sharing of information.
  • Serving as an SME by leading, training, and collaborating closely with cross-functional teams to ensure deviations/CAPAs/CRs are completed within pre-defined timelines.
  • Tracking and reporting quality metrics to senior management.
  • Direct experience in client communication to provide status updates, and supporting client and regulatory audits (Health Canada and FDA).
Qualifications and Skills
  • A minimum Bachelor’s university degree in a science discipline, with preference given to candidates with microbiology courses at the university level.
  • 5+ years of experience in Quality Management Systems with a focus on deviation investigation and CAPAs in the pharmaceutical field, with exposure to aseptic/sterile manufacturing environments.
  • Excellent working knowledge/understanding of GMP regulations (Health Canada and FDA) and industry expectations.
  • Expertise in root cause analysis methodologies and tools (e.g., 5 Whys, Fishbone diagram, FMEA).
  • ASQ or similar certifications in investigation and root cause analysis, desirable.
  • Excellent communication, interpersonal and influencing skills, with the ability to work effectively across departments and with external stakeholders.
  • Detail-oriented with strong organizational skills, able to manage multiple projects and priorities simultaneously.
  • Strong analytical and critical thinking skills, with the ability to assess risks and develop effective mitigation strategies.
  • Experience with client audits and regulatory inspections.
  • Proficient in the use of Microsoft software and Trackwise or other eQMS.

We offer a competitive salary plus potential bonus, benefits as well as an excellent opportunity to build your career with a well-established company with a corporate culture based on excellence.

While we appreciate all applications received, only those selected for an interview will be contacted.

Job Types: Full-time, Permanent

Pay: From $75,000.00 per year

Benefits:
  • Casual dress
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Life insurance
  • RRSP match
  • Tuition reimbursement
  • Vision care
Flexible Language Requirement:
  • French not required
Schedule:
  • 8 Hour Shift
Education:
  • Bachelor's Degree (preferred)
Experience:
  • Quality Management System: 5 years (preferred)
  • Canadian GMPs, FDA GMPs: 5 years (preferred)

Work Location: In person

Analytical Chemist (12-month contract)

Job Description

We are seeking a skilled Analytical Chemist with a B.Sc. or a M.Sc. in chemistry and 3+ years of experience using HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills. This is a 12-month contract position.

You will be required to conduct the following:
  • Working in a very fast paced environment by performing analytical testing of assigned materials or products within required deadlines.
  • Use of analytical instruments to generate analytical data, instrumentation to include HPLC, FTIR, UV, Karl Fischer, pH meter, osmometer, and other analytical equipment as required.
  • Participate in the development and validation of methods as required.
  • Engage in Method Life cycle management for continuous improvement
  • Working closely with others in the group to maintain laboratory equipment and procedures.
  • Following all safety policies and maintaining a clean and orderly work area.
  • Maintenance and upkeep of instrumentation.
  • Maintenance of documentation, including lab notebooks, equipment logbooks and analytical data.
  • Interpretation of analytical data.
  • Provide analytical documentation support to Customer Service, Business Development and Product Development departments as required.
  • Summarize and present data in a professional/technical manner.
  • Write, implement and maintain SOP’s for the analytical laboratory.
  • Perform all GLP/GMP activities in compliance with GLP/GMP guidelines & Dalton SOP’s.
  • Actively participate in Laboratory investigations and support effective CAPA
  • Any other duties which might arise during the course of a project.

Job Type: Fixed term contract

Contract length: 12 months

Pay: From $27.00 per hour

Expected hours: 40 per week

Additional pay: Overtime pay

Benefits:

  • Casual dress
  • Flexible schedule
  • On-site parking

Flexible language requirement: French not required

Schedule: 8 hour shift

Application question(s): Are you comfortable to work 100% on site?

Education: Bachelor's Degree (preferred)

Experience:

  • Validation of new analytical test methods: 5 years (required)
  • method transfers, method verifications for small molecules: 5 years (required)
  • Writing test methods, SOPs, validation protocols & reports: 5 years (required)
  • HPLCs, GCs with various detectors: 5 years (required)
  • UV-vis, automatic titrators, pH meters: 5 years (required)

Work Location: In person

While we appreciate all applications received, only those selected for an interview will be contacted.

Microbiologist (12-month contract)

This is a 12-month position. We are looking for Microbiologist I, II and III according to the knowledge and experience.

Roles and Responsibilities:
  • Maintain documentation, including lab notebooks, equipment logbooks and microbiological data.
  • Perform all activities in compliance with GLP/GMP guidelines & Dalton SOPs.
  • Perform all activities in compliance with GLP/GMP guidelines & Dalton SOPs.
  • Work in a very fast paced environment performing duties within required timelines, including:
  • Routine Environmental monitoring of Grade A to D and support areas
  • Routine Environmental monitoring of aseptic environments GRADE A/B
  • Environmental monitoring of aseptic environments GRADE A/B and personnel during Production/Media Fills
  • Read EM plates, isolate, purify and identify microorganisms (Bacteria and Molds) with particular attention to pathogenic microorganisms
  • Gram staining and microscopic examination of slides
  • Perform trend analysis of viable and non-viable data obtained from the GMP area
  • Inspect/transfer media filled vials
  • Conduct growth promotion testing and microbial ingress test
  • Receive media/reagent/components
  • Prepare media and reagents
  • Complete safety and laboratory inventory check lists
  • Clean of work benches and laboratory equipment
  • Conduct endotoxin testing and microbial testing/identification, as needed, on raw materials, intermediates, products and water
  • Execute method and EM validation protocols
  • Assist with training to new employees and/or new procedures
  • Assist the implementation of audit observation corrections.
  • Assist with deviation investigation/write deviations and develop CAPAs
  • Perform other duties as assigned by management.
Requirement:
  • B.Sc. or higher degree in Microbiology or related degree/diploma
  • 1 to 5+ years of experience in a microbiology laboratory in a pharmaceutical company

OR

  • Diploma in Microbiology or a related field
  • 2 to 7+ years of experience in a microbiology laboratory in a pharmaceutical company (more years of experience in a non-pharmaceutical setting will be considered)
  • Strong oral/written communication and interpersonal skills.
  • Experience in basic microbiological techniques
  • Working knowledge of Good Laboratory Practices
  • Must be willing and able to work in a structured work environment with regard to safety and consistent conformance to standard operating procedures and workplace practices.
  • Ability to be gown qualified to work in aseptic manufacturing areas
  • Good command of Microsoft Office and general computer skills.

Job Type: Fixed term contract

Contract length: 12 months

Pay: From $25.00 per hour

Additional pay: Overtime pay

Benefits:

  • Casual dress
  • Flexible schedule
  • On-site parking

Flexible language requirement: French not required

Schedule: 8 hour shift

Application question(s): Are you comfortable to work 100% on site?

Education: Bachelor's Degree (preferred)

Experience: Microbiology: 1 year (required)

Work Location: In person

While we appreciate all applications received, only those selected for an interview will be contacted.

QA Associate (12-month contract)

We are seeking a skilled Quality Assurance Associate with high energy level and initiative, to ensure that products manufactured at Dalton Pharma Services for human use are safe and meet the pre-determined quality specifications, and that Dalton Pharma Services follows the applicable regulatory guidelines for GMP (e.g. Health Canada, FDA and ICH) and maintains a state of compliance.

Responsibilities:
  • Assist in providing GMP operational guidance to All Dalton employees.
  • To ensure that documents in use have been properly approved, meet the GMP requirements and are current.
  • To review and approve new documents such as master batch records, test specifications and SOPs.
  • To review and approve executed documents, such as batch records, work sheets and material release documents.
  • Perform or review deviation investigations, operational investigations in particular, and ensure appropriate CAPA are put in place.
  • Review and approve Master Batch Records to ensure they meet Dalton SOPs, Customer expectations and regulatory requirements.
  • Review and sign off executed batch record packages (checklist). Including, but not limited to, Sterile Products.
  • Review and approve Media Fill protocols and reports
  • Perform or support deviation investigations, write/review associated impact assessment and determine/confirm root cause analysis.
  • Help to develop and review/approve SMART CAPAs. Determine appropriate effectiveness checks and ensure CAPA closure.
  • Assist with the implementation of CAPAs by reviewing CRs and ensuring timely implementation.
  • Write, review and/or approve Standard Operating Procedures.
  • Perform AQL inspections of finished product filled vials
  • Perform aseptic coaching (observe operations during filling) and spot checks.
  • Participate and provide QA support in regulatory inspections.
  • Review IQ/OQ/PQ protocols and reports.
  • Review risk assessments.
  • Review EM trend data reports.
  • Provide QA support in project calls when required.
  • Understand project and client requirements and match them with regulatory requirements.
  • Assist during customer audits, perform self-inspections and help to provide responses to external audits.
  • Administrative functions – attend meetings, timesheets, copying of documents for customers, creation of logbooks, filing of GMP documents and archiving of GMP records.
  • Perform other duties as assigned by QA management.
Qualifications:
  • B.Sc. in a science discipline
  • Microbiology Courses at the university level
  • Working knowledge of GMP regulations (Health Canada and FDA).
  • More than 5 years' experience in the pharmaceutical field.
  • Experience in the area of QA compliance.
  • Exposure to aseptic/sterile manufacturing.
  • Strong verbal, communication and interpersonal skills
  • Good command of Microsoft Office and general computer skills.

Job Type: Contract

Contract length: 12 months

Pay: From $27.00 per hour

Additional pay: Overtime pay

Benefits:

  • Casual dress
  • Flexible schedule
  • On-site parking

Schedule: 8 hour shift

Application question(s): Are you comfortable working 100% on site?

Education: Bachelor's Degree (preferred)

Experience:

  • Pharmaceutical Quality Assurance and Compliance: 3 years (preferred)
  • GMP Sterility Assurance: 3 years (preferred)
  • Canadian GMPs, US cGMP’s, Health Canada, FDA: 3 years (preferred)
  • interacting with regulatory agencies in an audit setting: 3 years (preferred)

Work Location: In person

While we appreciate all applications received, only those selected for an interview will be contacted.

QC Document Reviewer (12-month contract)

The primary role of the QC Document Reviewer is to ensure that the manufactured products and services provided by Dalton Pharma Services are GMP-compliant and follow Health Canada, FDA and ICH guidelines .

Role and Responsibilities:
  • Analyzing Data or Information – Identify the underlying principles, reasons, or facts of information by breaking down information or data into separate parts
  • Technical Writing - Participate in various aspects of development and validation programs, including but not limited to writing or review of Method Development Protocols and Reports, Validation Protocols and Reports and Test Methods.
  • Works with co-workers and other staff members with tact, courtesy and sincerity in personal contacts; appreciation for other people’s problems and ideas; positive impact on group dynamics
  • Reliable under varying circumstances, including attendance and timeliness.
  • Works with clients, Account Managers, Analytical Supervisors, Microbiology and QA to full fill needs and expectations of new and on-going analytical programs, trending requirements and other documentation needs.
  • To review all Raw Materials and Components Analytical data results based on USP/EP and test methods requirements and regulations
Requirements:
  • 5 or more years’ experience in a quality control documentation setting in a pharmaceutical company.
  • Candidates with demonstrated analytical experience and documentation experience will be preferred.
  • Demonstrated technical expertise and a broad understanding of cGMP, ICH, FDA guidelines and global regulatory affairs.
  • xcellent oral/written communication and interpersonal skills
  • olid interpersonal and technical writing skills.
  • Must be willing and able to work in a highly structured work environment with regard to safe and consistent conformance to operating procedures and work place practices.
  • Excellent knowledge of the Canadian GMPs, FDA cGMP’s, ICH guidelines and applicable regulatory guidelines.
  • Good command of Microsoft Office and general computer skills.

Job Type: Contract

Contract length: 12 months

Pay: From $28.00 per hour

Expected hours: 40 per week

Additional pay: Overtime pay

Benefits:

  • Casual dress
  • Flexible schedule
  • On-site parking

Schedule: 8 hour shift

Experience:

  • Bench work experience in analytical : 3 years (required)
  • Quality Control Documentation: 5 years (required)
  • cGMP, ICH, FDA guidelines and global regulatory affairs: 5 years (required)

Work Location: In person

While we appreciate all applications received, only those selected for an interview will be contacted.

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