Lab Analyst (hplc, Gc Analyst)
Newmarket, ON, Canada
Job Description
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Job Summary Quality Control Lab Analyst, under the direction of the Quality Director, is performing analyses to examine the quality of raw materials, in-process materials, finished goods, products on stability, cleaning verification samples following written procedure and applicable SOPs and ensure compliance with established standards and monitoring the quality of products and processes in strict compliance with the Regulations and GMP standards. Duties and Responsibilities
Screening Education:
- Performs physical and chemical analysis on in-process and finished products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as HPLC, GC, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs).
- Ability to perform calibration, suitability, and method validation for both HPLC and GC.
- Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
- Proficient and comfortable in laboratory instrumentation such as HPLC, GC, and various wet chemistry techniques.
- Conduct sampling and visual inspection of products at bulk, in-process and finished state as and when required. Submit samples to internal and/or external third-party laboratories for testing.
- Carry out environmental monitoring including but not limited to air and water monitoring.
- Compilation and documentation of results obtained from laboratories.
- Initiate and actively participate in an investigation of laboratory Out of Spec (OOS) results, when required.
- Perform analytical method validations and prepare data for review and reports
- Able to perform HPLC Maintenance and troubleshooting. Carry out periodic trending of results
- Conduct testing of raw materials and packaging materials to be used in the manufacturing of products.
- Preparation of documents like specifications for products, SOPs, study protocols, risk assessment, change control, and others.
- Support other departments in investigation of deviations, customer complaints, etc.
- Must follow safe practices as identified in the appropriate MSDS and WHMIS during working with chemicals, and must follow the policy of Health and Safety and OHS regulations
- Other duties as assigned by Quality Director
- BSc/MSc in Chemistry, Biological Sciences/ Pharmacy\xe2\x80\xafor post-secondary diploma in Science related technical discipline
- Previous work experience with a Canadian Licensed Producer (LP) is considered an asset
- Previous experience in Quality Control in pharmaceutical or related industries is considered an asset
- Minimum of 1 to 2 years of experience in Quality Control
- Proficient in English
- Excellent skills technical writing and GMP documentation skills.
- Excellent problem-solving, planning, and organizational skills
- Working knowledge of GMP, GLP, HACCP is an asset.
- Company events
- Extended health care
- On-site parking
- French not required
- 12 hour shift
- Day shift
- Holidays
- Monday to Friday
- Overtime
- Weekend availability
- Overtime pay
Screening Education:
- Bachelor\'s Degree (preferred)
- HPLC, GC testing, calibration, and suitability: 2 years (required)
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Job Detail
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Job IdJD2145769
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNewmarket, ON, Canada
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EducationNot mentioned