Quality Control Specialist

At a top 10 Global Biopharmaceutical employer, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Are you looking for a patient-focused, innovation-driven company that will inspire and empower you to shine? Join us as a

Quality Control Validations Specialist

at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission. Title

Quality Control Validations Specialist Location

Thousand Oaks, CA - Onsite Duration

12 month potential for extension based on project need Pay

Desirable, negotiable Role Description The candidate will be part of the Quality Control Validation (QCV) team responsible for: Reviewing and approving validation documents (e.g., test plans, protocols, reports,) and other related documents to ensure compliance to internal procedures and regulatory requirements. Ensuring that the information contained in the approved validation document(s) is understandable and defendable during inspections. Executing Test Method transfers, investigation, technical writing Supporting site project validation activities, working as part of the QAV and project teams to review and approve documents in a timely manner, ensuring all cGMP regulatory requirements are met. Candidate Experience The candidate will require a high degree of experience working in a cGMP biopharmaceutical environment with an understanding of FDA, ICH, EU regulations. Must Haves 4+ years' experience Quality Control, specifically with Validation Process Executing Test Method transfers, Test Methods, troubleshooting, investigations Strong interpersonal communication skills with excellent technical writing abilities. Method verification protocols, SOP and worksheet, Execution of protocols, Methods reports Experience with Bio burden, Endotoxin, Growth Promotion, Identification, Identity – HPLC, ID-Osmolality, Material Appearance, Osmolality, Solubility, Sterility Knowledge of the current ISPE Baseline Guidelines for Commissioning and Qualification and GAMP5. Experienced in reviewing and approving Life Cycle Validation Documents including: Familiar with paperless validation software for life sciences Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant. Computer System Validation protocols and reports, including SCADA, MES. QC/Micro Laboratory Instrument Qualification and method validation.