M&A Analyst supporting search, due diligence, and execution of software acquisitions. Partner One invests in and grows successful enterprise software companies.
About the role
- Quality Control Analyst II performing chemistry and biochemistry testing for Grifols’ plasma-derived healthcare products. Maintaining GMP compliance, instruments, documentation, and analytical method validation support.
Responsibilities
- Perform chemical and biochemical analyses using approved methods
- Conduct testing to support manufacturing operations and validation activities
- Analyze samples of raw materials, plasma-derived products, and services/utilities
- Maintain the calibration, verification, and qualification of laboratory equipment
- Maintain instrument usage and calibration records
- Manage inventory and order, store, and receive laboratory supplies
- Perform activities in accordance with GMP/cGMP requirements
- Draft and revise standard operating procedures (SOPs)
- Perform testing in accordance with USP, EP, and BP pharmacopoeias
- Prepare reagents, clean equipment, and perform routine equipment maintenance
- Identify and report OOS, OOT, or atypical results and participate in laboratory investigations
- Complete GMP documentation and ensure data integrity and traceability
- Support method transfers and analytical method validation studies
- Participate in complex projects and develop expertise in analytical techniques
Requirements
- Minimum of a bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
- Experience in a biotechnology or pharmaceutical quality control laboratory is strongly preferred
- GMP experience is required
- Minimum of three (3) years of experience working in a GMP laboratory role
- Working knowledge of cGMPs, the QC laboratory environment, and equipment used for biopharmaceutical product testing
- Knowledge of GMP requirements and the USP, BP, and EP pharmacopoeias
- Knowledge of good documentation practices and data integrity requirements
- Excellent computer skills, including Microsoft Office (Word and Excel)
- Experience with LIMS is preferred
- Bilingual in French and English
- Ability to work independently and as part of a team
- Ability to manage multiple tasks simultaneously and meet strict deadlines
- Excellent oral and written communication skills
- Ability to carefully follow written procedures with strong attention to detail
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