Product Quality Specialist supporting quality, testing, documentation, and commercialization of algal omega - 3 products at Mara Renewables. Collaborating across Quality, Regulatory, Operations, and Commercial teams in hybrid Dartmouth role.
About the role
- QC Instrumentation Specialist at Grifols supporting qualification and maintenance of laboratory instruments. Collaborating with QC teams to ensure compliance with industry standards in a cGMP environment.
Responsibilities
- Install, maintain, diagnose and troubleshoot laboratory analytical equipment (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).
- Maintain and review calibration data associated with instruments and report changes in performance.
- Provide the expertise required to manage installation/operational and performance qualifications (IQ/OQ/PQ) for quality control laboratory instruments.
- Assist in preparing IQ/OQ/PQ and validation reports for laboratory instruments.
- Develop and/or update equipment calibration and verification procedures.
- Support the QC department in investigations related to instruments and temperature-controlled units.
- Notify the QC Laboratory Manager of any potential quality issues related to instruments and temperature-controlled laboratory units and provide recommendations for quality improvement.
- Assist in implementing corrective actions related to audit findings concerning instrument validations.
- Coordinate instrument calibration and maintenance, manage spare parts inventory, and liaise with vendors.
- Advanced knowledge of maintenance management via SAP to collect information on calibrations and preventive maintenance.
Requirements
- B.Sc. (preferred) in biochemistry, physics, or a life sciences field.
- At least six years of experience in the same role within a quality control laboratory in a cGMP environment in the pharmaceutical or biotechnology industry.
- Strong communication, interpersonal, organizational, and decision-making skills.
- Strong technical writing skills.
- Advanced knowledge and skills for computerized systems used with laboratory equipment.
- Knowledge of GMP and pharmacopoeias (USP, BP, EP) to support products for the Canadian, US and European markets.
- Advanced knowledge of qualification of computerized analytical systems, data integrity requirements, and computer system validation for laboratory system applications.
- Proficiency in MS Office (Excel, Word and PowerPoint) and strong experience with software/systems related to pharmaceutical applications.
- Bilingual in French and English preferred (proficiency in English is required to handle documentation and communications with other Grifols sites outside Quebec and Canada (Spain, USA)).
Benefits
- Health insurance
- Professional development
- Paid time off
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