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Quality Control Instrumentation Specialist
GrifolsQC 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.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- Professional development
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
TOCHPLCGCIRUV-VISICKarl FischerMALDI BiotyperEndotoxin SystemELISA
Soft Skills
Strong Communication SkillsInterpersonal SkillsOrganizational SkillsDecision-Making Skills