Quality Control & Quality Assurance

Quality Control, Quality Assurance & Microbiology

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.

Please forward your resume to:

Human Resources Department
Dalton Pharma Services Inc.
Email:

POSITIONS CURRENTLY AVAILABLE:


Laboratory Compliance Team Leader

We are seeking an experienced Laboratory Compliance Team Leader to join our team. As a Laboratory Compliance Team Leader you hold a MSc or BSc in Chemistry with 5 yrs. leadership experience in a GMP quality control environment. You have had involvement directly leading FDA and Health Canada inspections with successful outcomes within the past 3-5 years. Hand-on experience in OpenLab software and instrumentation validation is a requirement. Able to develop, administer and coordinate the schedules and technical activities of a QC team up to 10 staffs. You must possess strong oral and written English communication skills.

The Laboratory Compliance Team Leader is responsible for the following in the QC lab:

  • Ensuring Data Integrity in the QC department, including CFR 21 Part 11 Compliance of testing activities and equipment
  • Developing and implementing e-lab solutions: training support, troubleshooting (SME)
  • Ensuring the equipment and test methods used are validated and compliant with cGMP requirements
  • Be backup to IT as ‘administrator’ for OpenLab and other computerized lab systems
  • Participating and leading non-conformance lab investigations, including experiments to demonstrate correct methods/technique and help with overflow
  • Providing technical feedback, coaching and mentoring to direct reports
  • Direct reports will include Laboratory Compliance Specialist(s), Sample Coordinators and other Lab Support personnel
  • Checking for adequate equipment, consumables, resources and materials for efficiency and compliance, including requesting cal/val as required, waste removal
  • Oversee testing in compliance with applicable cGMPs
  • Being a resource to help analysts complete their work – providing guidance and mentoring
  • Performing Spot-check/monitoring lab compliance, such as notebooks and analysts for compliant work and documentation
  • Ensuring that QC activities required for compliance are current and completed ahead of schedule or on time (e.g. biennial reviews of SOPs, New SOPs, validations etc.)
  • Awareness of Health and Safety requirements
  • Participating in URS and selection/procurement and validation of equipment and software as required
  • Preparation of forms and spreadsheets, including validation if required
  • Writing of reports, trends or protocols may be required

Laboratory Compliance Specialist

We are seeking an experienced Laboratory Compliance Specialist to join our team. As a Laboratory Compliance Specialist you hold a BSc in Chemistry with 5 yrs. experience in a GMP quality control environment. Hand-on experience in analytical/QC laboratory.

The primary purpose of this position is to prepare documents required by the Quality System to ensure compliance with GMPs.

Experience and responsibilities of the Laboratory Compliance Specialist include:

  • Deep understanding of FDA and Health Canada guidance on Lab OOS investigations
  • Hand-on experience in conducting laboratory investigations
  • Extensive experience with writing laboratory investigations
  • Excellent oral/written communication and interpersonal/leadership skills
  • Engage in very close communication with Quality Assurance team members, Analytical Chemists and Microbiologists
  • Ability to work in a structured work environment with regard to safety and consistent conformance to standard operating procedures and work place practices
  • Other technical writing and documentation related to GMP Compliance will be required
  • As part of any investigations and validation work, you will be involved in the interpretation of data generated. Knowledge of simple statistics is an asset
  • To ensure compliance of the instrumentation and software you will participate in formal and informal audits of the laboratory

Quality Assurance Associate

We are seeking a skilled Quality Assurance Associate with high energy level and initiative, You should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology, to 2-5 years Quality Assurance or Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs , US cGMP’s , FDA and ICH guidelines and strong verbal and written communication skills.

You will be responsible for maintaining and improving quality compliance, creating, reviewing and approving Standard Operating Procedures, reviewing and approving documents related to specification, analytical testing, production, such as batch records and associated testing data, validation protocols, calibration records, stability programs, deviations, OOS documentation, trending, and document control.


Director of Quality

At Dalton, our people are our greatest strength, and our success has been built on our technical capabilities and the way we manage our relationships with each other. Our culture is supportive and innovative, driven by some of the Industry's best and brightest people helping us make the impossible possible, compliantly. Are you at the point in your career where you are looking for an environment where you’re inspired to explore your passions, where your talents are nurtured and cultivated? Do you strive to innovate with leading-edge scientific technologies? If so, join our team of innovative drug developers working together to bring innovative, life changing discoveries to the global market. Dalton is a fast paced environment and has experienced tremendous growth in the recent years.

We are currently looking for an experienced Director of Quality to work in a pharmaceutical manufacturing environment to lead and manage the strategic and operational performance of the Quality, QC and Microbiology Departments, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, while following to all regulatory compliance.

To qualify for this position, the candidate must possess the qualifications:

Duties would include, but not be limited to:

  • Oversee operational activities in QA, QC and Microbiology areas to ensure timely completion of various of project tasks
  • Establish and maintain Quality Systems and Procedures to ensure that the products and services are in compliance with cGMP requirements
  • Host regulatory inspections and customer audits
  • Prepare reports and other documentation required by regulatory agencies
  • Establish, track and review quality performance indicators and trends
  • Provide quality guidance and training
  • Make a final decision about disposition of products

Education & Experience Requirements

  • Minimum B.Sc. in a related science
  • Strong leadership/team management skills.
  • You must have excellent knowledge of the Canadian GMPs and FDA cGMP guidelines.
  • 10+ years Quality Management (QA, QC, Microbiology) experience in the pharmaceutical industry
  • Strong verbal and written communication skills
  • Strong interpersonal skills

Head of Quality Control

Dalton Pharma Services is a market leader in pharmaceutical contract research and manufacturing, the winner of CMO Leadership Awards in the past three consecutive years and has been recognized as one of the Top 50 Best Workplaces™ in Canada in 2018, making its mark amongst Canadian leaders, innovators and visionaries. We have experienced tremendous growth and are currently seeking an experienced QC Professional to join our management team.

As an integral member of our Quality Team you will lead the development and execution of QC priorities and technical objectives for the business. Acting as an advisor and coach to your team of Quality professionals, you will provide required support to ensure that key project milestones and timelines are met and technical problems are resolved. You will be required to coordinate lab activities with other departments to optimize production needs and ensure that ongoing stability programs are executed timely.

Competencies and Requirements:

  • PhD or MSc in Chemistry
  • 5-10 years’ experience at the manager or director level in a cGMP Quality Control Environment in pharmaceutical industry
  • Hand-on experience in the preparation and hosting of FDA and Health Canada inspections with successful outcomes within in the past 5 years
  • Proficient in leading Laboratory Investigations
  • Familiarity with a wide range of analytical instrumentation, such as HPLC, GC, FTIR
  • Strong working knowledge of cGMP
  • Experience with quality control operations and principles of method and process validation
  • Effective client communication/interaction with strong oral and written English communication skills A proven leader in building and leading high performing QC Team

Microbiologist (6- 12 Month Contract)

We have an opportunity for a 6- 12 month contract Microbiologist position that lives in the Toronto area. This person will mainly be doing data entry and EM Trending and gram staining.

Requirements:

  • University degree in Microbiology
  • 1 or more years’ experience in a quality control microbiology laboratory in a pharmaceutical company.
  • Excellent oral/written communication and interpersonal/leadership skills.
  • Must be willing and able to work in a structured work environment with regard to safety and consistent conformance to standard operating procedures and work place practices.
  • Experience in basic microbiological techniques.
  • Experience in good laboratory documentation practices and regulatory guidelines e.g. SOPs, Pharmacopeias.
  • Solid interpersonal and technical writing skills.

Duties:

  • Working in a very fast paced environment by performing duties within required deadlines.
  • Work involves (1) Environmental monitoring of controlled environments (GMP areas) including aseptic fills, support areas and personnel (2) Isolation, purification and identification of microorganisms (Bacteria and molds) with particular attention to pathogenic microorganisms (3) Gram staining and microscopic examination of slides (4) Analysis of viable and non-viable data obtained from the GMP area (5) Growth promotion testing (6) Media/reagent receiving, quarantine, preparation and storage (7) Completion of safety and laboratory inventory check lists (8) Cleaning of work benches and laboratory equipment (9) Bioburden testing (10) Endotoxin testing (11) Water and material testing (12) Gowning qualification (13) Other microbiological tests as required
  • Maintain documentation, including lab notebooks, equipment logbooks and microbiological data.
  • Complete alert/action level forms and updates. • Maintain EM databases and trending of EM data as per SOP.
  • Select, interpret, modify and validate microbiological procedures. • Identify cost savings without compromising quality.
  • Provide support as per audit requirements and implement audit observation corrections.
  • Write and execute validation protocols and provide training to co-workers for protocol execution.
  • Provide training to new employees and training on new systems, equipment, etc. Solve problems in a professional manner.

Analytical Chemist

As an Analytical Chemist with a B.Sc. or M.Sc. in chemistry and 5+ years’ experience using ICP-OES & ICP-MS instrumentation, HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills.; You have great accuracy and precision in all testing that you conduct and interpretation of analytical data and technical report writing are your forté.

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