The Quality Control (QC) Analyst I / II is responsible for performing analytical tests in chemistry daily lab operations and execution of testing to support manufacturing operations or validation. Testing typically includes samples from raw materials, in-process intermediates, final drug product manufacturing, stability and various protocol studies using approved test methods. This position requires competent understanding and ability to perform techniques such as HPLC, GC, AAS, ELISA and UV spectrophotometry.
This position is expected to maintain operational and GMP readiness of the QC areas. Based on the level of this position, the individual in the Analyst II role is expected to participate in more complex projects including QC studies and to develop mastery of a diverse number of analytical techniques and fluency with analytical technologies.
Key Duties and Responsibilities
- Perform all lab functions in compliance with cGMP.
- Perform material, product, utilities testing for GMP use in manufacturing. Follow written procedures for the following tests as trained and qualified:
- TOC Analyzer
- Atomic Absorption Spectroscopy (AAS)
- IR Spectroscopy
- Gas chromatography
- UV – Vis Spectrophotometer
- Ion chromatography
- ELISA testing
- Compendial Methods such as pH, Osmolality, and Appearance.
- Perform analytical testing on raw material, intermediates, packaging components, finished product, utilities and other test articles as per approved methods, specifications, procedures and GMP.
- Perform analytical testing for the purpose of material/product release, validation and/or stability
- Perform QC instrument verification and qualification as needed.
- Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.
- Recognize and report aberrant test results and sample conditions. Report any out-of-specification (OOS), out-of-trend (OOT) or atypical results immediately to the QC Manager and participate in laboratory investigations, as required
- Ensure training is current for all job functions performed.
- Receive and manage samples that come into the lab for stability and release testing.
- Order, stock and receive laboratory supplies.
- Complete all required documentation legibly and accurately. Maintain Good Documentation Practices when completing logbooks, analytical work sheets, training records and all other GMP documents. Ensure the integrity and traceability of data generated
- Support the implementation of Laboratory Information Management System (LIMS) with the data entry and configuration of the future LIMS applications.
- Assist in management of retention and stability samples, as well as samples for destruction
- Collaborate with QC Manager to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
- Perform additional duties as assigned
- Minimum of a bachelor’s degree in a scientific discipline and experience in a Biotech or pharmaceutical QC Laboratory preferred. GMP experience required.
- A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
- Related experience: 2- 5 years, title is commensurate with the required experience
- Analyst I – 0 to 3 years of working experience in a GMP laboratory role
- Analyst II – 3 to 5 years of working experience in a GMP laboratory role
- Good knowledge of USP, Ph. Eur. Pharmacopeia.
- Knowledge of cGMPs, good documentation practices and data integrity requirements.
- Experience with LIMS systems preferred.
- Strong computer skills with MS Office (MS Word and Excel).
- Strong organizational skills, including attention to detail and ability to meet deadlines
- Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes.
- Ability to follow written procedures with close attention to detail.
- Must be an able to work independently and as part of a team
- Able to multi-task under strict deadlines
- Be proactive and resourceful to help prevent and solve problems
- Excellent oral and written communication skills and good interpersonal skills
- Bilingual in both French and English preferred
Job Type: Full-time
- French, english (Preferred)