Quality Control Analyst I

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

**Position Title**:Specialist QC Chemistry **Reports to**: QC Chemistry Supervisor

**Purpose Statement**

The **Incoming Quality Control Analyst (Specialist QC Chemistry)** 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, packaging components and utilities and executing various protocol studies using approved test methods. This position requires competent understanding and ability to perform techniques using UV spectrophotometry, HPLC, GC, and AAS and TOC.

He will be responsible for inspecting and sampling all raw materials that are used in production and packaging according to the Raw Material Specification (RMS) and associated approved procedures.

This position is expected to maintain operational and GMP readiness of the QC areas. Based on the level of this position, the Specialist QC Chemistry 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**
- Sample raw materials for QC testing and for the Reference Sample program.
- Perform identification test for all chemical containers.
- Perform visual inspections and dimensional analysis of incoming materials
- Record deficiencies associated with each lot received under the supplier quality history trending program.
- Review all inspection records to ensure entries are correct and completely fill out.
- Ensure all equipments used in the inspection and testing processes are calibrated.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Monitor and maintain the inventory level of supplies used in the inspection process.
- Perform all lab functions in compliance with cGMP.
- Writing and reviewing SOPs
- Perform Raw Materiel testing according to USP, EP and BP
- Perform analytical testing on raw material, packaging components, utilities and other test articles as per approved methods, specifications, procedures and GMP.
- Ability to perform techniques using UV spectrophotometry, HPLC, GC, and AAS and TOC.
- 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.
- 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
- Collaborate with QC Supervisor and Director to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
- Perform additional duties as assigned

**Qualifications**
- Minimum of a bachelor’s degree in a scientific (Chemistry or Biochemistry) or related 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: Minimum of 3 years of working experience in a GMP laboratory role
- Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European market
- 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 wri