Building Your Career with QCL

QCL-Quality Compliance Laboratories Inc. is a fast growing Canadian analytical contract testing and consultancy organization. Our organization provides superior and unparalleled comprehensive GLP/GMP Quality Control (QC) and Research and Development (R&D) analysis to support the pharmaceutical, biopharmaceutical, nutraceutical, and allied industries.

Due to our continuous growth, we are constantly on the lookout for highly qualified professionals to join a team committed to being the absolute best.

QCL’s adherence to quality and excellence has produced explosive company growth resulting in immediate openings for the following professionals:

• Validation Specialist
• Senior Quality Control and Validation Analyst
  (4 Positions)
• Senior Quality Assurance Specialist (3 Positions)
• Senior Quality Control Microbiologist (2 Positions)
  

Validation Specialist

Location: Markham, Ontario

Requirements:

Completed training on HPLC/GC Validation

Qualified as a Validation Specialist in the areas of HPLC/GC system Installation, Qualification (IQ), Preventive Maintenance (PM), Operation Qualification (OQ) and Performance Qualification (PQ)

Requires a thorough understanding of procedures and requirements for HPLC/GC system qualification.

Validation Specialist is authorized to act as the "Performer" in performing Validation Services IQ, OQ, PQ and PM's for HPLC/GC.

• Pumps
• Auto injectors
• UV Absorbance Detectors (VWD, DAD included)
• Fluorescence Detectors
• Refractive Index Detectors
• Electrochemical Detector
• Evaporative Light Scattering Detector
• Familiar with Empower Systems

Education and Experience:

• Minimum 5 years related experience in the pharmaceutical industry
• Bachelor degree in Engineering or Science in a related discipline.
• Demonstrated knowledge of validation concepts.
• High level of familiarity with Excel, Word, Access required.
• Proven organizational, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast paced environment.
• Excellent English oral and written communication skills.
• Knowledge of GMP/GLP
• Excellent problem solving skills
• Proven organization and time management skills as demonstrated through previous work and/or educational experience.

General Skills:

• You must be willing to work in a team-based environment
• You must have the ability to analyze data
• You must be attentive to details
• You must have excellent computer skills
• You must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required.

Senior Quality Control and Validation Analyst (4 Positions)

Reports To: Laboratory Manager
Location: Markham, Ontario (1 position)
Location: Montreal, Quebec (3 positions)

Primary Responsibilities:

Working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimum guidance.

The position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, and AA testing on raw materials, in-process and final products per established SOP's and pharmacopoeial product specifications.

• Documenting and reporting results in accordance with GMP and GLP
• Providing technical support to your peers.
• Design test methods and validation experiments ensuring analytical accuracy and cost effective methodology
• Generating method validation Protocol and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, client’s specification, and regulatory guidelines
• Perform method development and method validation for API, In-process, and Finish Products.
• Responding and Trouble-shooting of complex issues with respect to laboratory analysis and laboratory instrumentation
• Providing technical support within and outside the department. 
• Performing all work in accordance with all established regulatory, compliance and safety requirements
• Training junior analysts as required
• Maintaining professional relationship with internal/external customers
• Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings.
• Revising and updating existing methods when required 
• Performing tests for Certification of Analysis or Raw Material and Finished Products within assigned time period.
• Maintaining accurate and complete records.
• Participating in the development and/or providing recommendations for department SOPs and procedures 
• Assists in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP 

Education and Experience:

• University Degree in Science – Majoring in Chemistry
• Minimum of 3 years Quality Control experience in the Pharmaceutical industry in particular contract testing.
• Knowledge of GMP, GLP, Compendia, analytical techniques and method validation.
• Superior organizational and interpersonal skills.
• Ability to manage multiple projects and tasks concurrently and effectively
• Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, ICP, TOC, etc.
• Sound understanding of current GMP, ICH and FDA requirements.
• Excellent written and oral communication skills is a must
• Computer proficiency with MS Office programs.
• Ability to meet deadlines and prioritize tasks with strong attention to detail.

General Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• You must be willing to work in a team-based environment
• You must have solid math skills
• Must be able to work with limited direct supervision
• You must have good problem solving/organizational skills
• You must have excellent computer skills
• You must demonstrate good written and oral communication skills in English and French  if applying for Montreal operation
• You must have the ability to analyze data
• You must be attentive to detail
• You must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required

Senior Quality Assurance Specialist (3 Positions)

Reports To: Manager of Quality
Location: Markham, Ontario (1 position)
Location: Montreal, Quebec (2 positions)

Primary Responsibilities:

Outstanding opportunity for Quality Assurance professionals to join our company based in both Toronto (1 position) and Montreal (2 positions) as Senior Quality Assurance Specialists.

As the Quality Assurance Specialist you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice), and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews and analysis.

Responsibilities:

• Manage the GMP Documentation, Change Control, CAPS, OOT, OOS, Training Record systems.
• Review and approve CoA and other quality documentation
• Review validation activities
• Assess regulations  
• Develop quality policy
• Perform timely data review with a high focus on data quality to ensure accuracy and completeness of analytical testing documentation.
• Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
• Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
• Review internal logbooks for incoming samples, standards, reagents, equipment etc.
• Issue and reconcile Quality Control laboratory workbooks and other GMP documentation.
• Audit and inspect laboratory equipment daily use logbooks
• Ensure analysis performed are as per  client’s specification
• Track tests in progress and issue periodic status reports
• Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
• Implement Quality Policies and Procedures for on-site test activities
• Develop, implement and update QA Manual, QA Supplement Manual and standard operating procedures
• Prepare, review and approve Standard Operating Procedures (SOPs)
• Coordinate documentation activities to ensure compliance with GLP and GMP
• Archive and retrieve quality control data
• Audit and inspect laboratory operation and activities
• Audit and review data for accuracy, completeness and regulatory compliance
• Detailed audits of draft reports for compliance with SOP’s and GLP regulations
• Participate in client audits and inspections
• Participate in regulatory audits and inspections
• Oversee the laboratory investigation
• Perform Annual Internal Audit, and work with Analytical Lab personal to ensure follows up and corrective actions are completed.
• Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
• Data-review and data-verification activities
• Maintaining and issuing controlled numbers in support of site-wide document control
• Tracking document requests and ensure completion of outstanding items
• Conduct QA investigation with regard to Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
• Assist in the review and approval of GMP documents such as SOPs, and associated forms, and initiate revisions.
• Evaluate laboratory results and keep trending of QCL Stability studies and write assessment reports of these programs annually.
• Any other tasks assigned by the QLC senior management

Education and Experience:

• University Degree in Science – preferably in Chemistry coupled with experience in the review of raw material, finished product, stability and analytical method validation documentation.
• Have experience in a Quality Assurance leadership role with minimum of 3 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
• Have expert experience of GMP Thorough understanding of pharmaceutical QA Systems, US, EU, and Canadian GMP regulations
• Knowledge of GMP, GLP, Compendia, analytical techniques and
• You should have excellent verbal and written communication skills, interpersonal skills and you should be extremely results driven and organized
• You must demonstrate good written and oral communication skills in English and French  if applying for Montreal operation

General Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Must be willing to work in a team-based environment
• Must have solid math skills
• Must be able to work with limited direct supervision
• Must have good problem solving/organizational skills
• Must have excellent computer skills
• Must have strong writing and communication skills in English
• Must have the ability to analyze data
• Must be attentive to detail
• Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required

Senior Quality Control Microbiologist (2 Positions)

Reports To: Laboratory Manager
Location: Markham, Ontario (2 positions)

Primary Responsibilities:

• Perform a variety of tests for microbiological assays including microbial limit test, diagnostic test for designated organisms according to client’s requirements and methods, SOPs, current compendial USP, EP, BP, and ICH guidelines for microbiological testing.
• Perform a variety of tests including microbial limit test, water testing, preservative challenge test for pharmaceutical products
• Perform environmental monitoring and identify recovered organisms and media preparation, growth promotion test for every culture media.
• Perform temperature monitoring of incubators, refrigerators, and micro lab.
• Perform autoclave operation and maintenance
• Maintain microbial stock culture collection
• Maintain good documentation systems and report formats for all laboratory procedures, processes and equipment.
• Ensure all analysis performed meet GMP and regulatory and compendial requirements
• Provide training and technical leadership to less experienced staff
• Ensure optimum performance of laboratory via supporting activities such as ordering lab supplies and maintenance of equipment, as well as execute qualification / validation activities
• Participate in investigations and document non-compliance or out-of-spec situations regarding any microbiological test

General Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Be willing to work in a team-based environment
• Have solid math skills
• Be able to work with limited direct supervision
• Have good problem solving/organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
• Have excellent computer skills
• Have the ability to analyze data
• Be attentive to detail

Education and Experience:

• University degree in Microbiology, or related science
• A minimum of 3 years microbiology laboratory experience in pharmaceutical industry
• Sound knowledge of practical microbiological assays
• Sound understanding of USP, EP, BP, GMP, cGMP and ICH guidelines for microbiological analysis
• Computer proficiency with MS Office programs.

If interested, submit your resume (in MSWord format) to info@qctest.com , ATTN: Human Resources

Please note only suitable candidates will be contacted