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. 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.

Experience Required

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 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 behavior 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.

Qualifications and Skills

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 guidance’s, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
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.

Analytical Chemist II/Senior Analytical Chemist

We are seeking a skilled Analytical Chemist II/Senior 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.

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

Quality Assurance Associate (Operations)

We have an opportunity for a full-time Quality Assurance Associate (Operations) position. The individual must have a high energy level and initiative and live in the Toronto area

The successful candidate should meet the following qualifications and requirements:

Requirements

B.Sc. or higher degree in a science discipline
Microbiology Courses at the university level
5+ years Quality Assurance and Compliance experience in the pharmaceutical industry
Excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines
Hands-on experience in:
- Writing/reviewing/approving new documents such as master batch records and SOPs
- Reviewing and approving executed documents, such as batch records, work sheets and material release documents
- Performing or reviewing deviation investigations, operational investigations in particular, and ensure appropriate CAPA are put in place
Strong verbal and written communication skills.
Experience in interacting with regulatory agencies in an audit setting and correspondence would be an asset.
Exposure to an aseptic/sterile manufacturing environment
Proficient in the use of Microsoft software and Trackwise

Quality Assurance Associate (Compliance)– 16 Month Contract Position

We have an opportunity for a 16-month contract Quality Assurance Associate position that lives in the Toronto area with high energy level and initiative, you should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology or 5+ years Quality Assurance and QA Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines and strong verbal and written communication skills. Experience in interacting with regulatory agencies in an audit setting and correspondence would be an asset. Experience in a QC laboratory setting and instrumentation.

Responsibilities:

Perform or approve deviation, especially QC LIR/LE 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.
Review CRs related to CAPAs and ensure they are implemented and closed in a timely manner.
Review test methods and associated protocols, as applicable.
Ensure that Dalton employees follow GDP on all documents and maintain compliance.
As part of the self-inspection team, perform internal audits to ensure SOPs and regulatory requirements are met.
Work with Supervisor to ensure GMP Material Vendors, GMP Contractors and GMP Service Providers are audited as per schedule.
Participate, prepare documents, and provide support during regulatory/customer audits and preparing responses to audit observations.
Assist with external audit readiness (Regulatory inspection and Client audits), participate in audit/inspections and prepare audit responses.
Write, review and/or approve Standard Operating Procedures.
Review Logbooks for compliance and completion.
Support investigations of product and vendor complaints and product recalls.
Assist with the writing of annual product reviews and in the creation of trend reports of quality systems.
Prepare and execute mock recall under the guidance of the supervisor.
Administrative functions – attend meetings, timesheets, copying of documents for customers, creation of logbooks, filing of GMP documents and archiving of GMP records.

QC SENIOR DOCUMENTATION REVIEWER

As a QC Senior Documentation Reviewer with a University degree in chemistry and 5 or more years’ analytical testing and data reviewing experience in a quality control laboratory in a pharmaceutical company, you are logical and have excellent oral and written communication skills. Employ interpersonal/leadership skills within a structured work environment and consistent conformance to standard operating procedures and workplace practices. You demonstrate technical expertise and a broad understanding of cGMP, GLP, ICH, FDA guidelines, fluent in USP, Ph. Eur., JP compendial requirements and have great accuracy and precision in all the activities that you conduct, and interpretation of analytical data and technical report writing are your forté.

You are fluent in cGMP activities, and documentation requirements for ALCOA. You have great attention to detail in all the work that you perform, and a quick mind for computations and trends. You are an expert at interpretation and evaluation of analytical data.

You will be required to understand and review data carried out using a wide variety of equipment including HPLCs with UV, DAD, ELSD and electrochemical detectors, GCs (including capillary column and headspace) with FID and TCD detectors, ICP-MS, EA, Karl-Fischer, UV-vis, FTIR, Osmometer, automatic titrators, pH meters, and wet chemistry analysis. In dept knowledge of OpenLab, Content management and Trackwise is an asset.

You will be required to actively participate in various aspects of development and validation programs, including the writing or review of Method Development Reports, Stability Studies, Validation Protocols and Validation Reports; Methods life cycle management and Change controls.

The duties assigned to this QC Senior Documentation Reviewer role consist of:

Review and interpretation of data generated by the QC department
Data integrity check and audit trail review
Assessment and investigation of anomalous results and must ensure that the data is correct, accurate and its quality meets requirements (GMP, Regulatory and Dalton internal) prior to submitting it to QA in a timely manner
Review Method Validations/Method Qualifications/Method Transfers Analytical results and reports based on protocol’s criteria and requirements
Review all Stability data generated by QC department including trending reports and protocols.
Support QC lab Quality events and other investigations, (i.e., act as Investigator, perform RCA, define and implement CAPA)
Advocate cGMP, consistent documentation, and actively participate in continuous improvement projects.
Write, review, revise, implement and maintain SOP’s for the analytical laboratory.

Dalton’s vision is to benefit the world by being the ultimate drug development resource. We offer full service in drug development and manufacturing capabilities, including peptide and small molecule API synthesis, as well as sterile fill of finished products in our world-class GMP facilities.