- 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.
- 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.
- 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. xhmxlyz
- Computer System Validation protocols and reports, including SCADA, MES.
- QC/Micro Laboratory Instrument Qualification and method validation.
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Quality Control Specialist - Thousand Oaks - Randstad
Description
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.
Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description.
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:
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:
Experienced in reviewing and approving Life Cycle Validation Documents including:
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Quality Control Specialist
Only for registered members Thousand Oaks
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Quality Control Validations Specialist
Only for registered members Thousand Oaks
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Quality Control Validations Specialist
Only for registered members Thousand Oaks, CA
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Document Control Specialist
Only for registered members Calabasas, CA
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Inventory Control Specialist
Full time Only for registered members Moorpark
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Material Control Specialist II
Only for registered members Simi Valley
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Material Control Specialist II
Only for registered members Simi Valley, CA
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Material Control Specialist II
Freelance Only for registered members Simi Valley
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Material Control Specialist I
Only for registered members Simi Valley, CA
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Material Control Specialist II
Only for registered members Moorpark
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Material Control Specialist II
Full time Only for registered members Moorpark
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Senior Business Control Specialist
Only for registered members Moorpark
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Material Control Specialist I
Only for registered members Simi Valley
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Material Control Specialist I
Freelance Only for registered members Simi Valley
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Senior Business Control Specialist
Only for registered members Moorpark, CA
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Material Control Specialist II
Only for registered members Moorpark, CA
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Program Control Specialist
Only for registered members Beverly Hills
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Quality Control Specialist
Only for registered members Culver City
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Quality Control Specialist
Only for registered members Culver City, CA
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Accounting Controls Specialist
Only for registered members Sun Valley, CA