TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client leading biotechnology company and combines technological insight with world-class manufacturing, scientific expertise and process excellence, and help their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: QA Specialist II

Location: Hayward CA 94545

Duration: 6 Months

Job Type: Contract

• This role is responsible for the review and approval of GMP documentation to ensure compliance in operational areas.
• Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities.
• Participates in deviations and root cause investigations.
• Focused responsibilities include batch record review, and review of QA Operations related SOPs to meet local, Global and Regulatory requirements.

• Responsible for the review and approval of cGMP documentation against Standard Operating Procedures in order to ensure compliance in Manufacturing processes.
• Raise deviations as needed in order to capture potential impacts to product quality.
• Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
• Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
• Participates in deviations and root cause investigations.
• Identify areas of non-conformance. Complete minor deviations and support root cause investigations.
• Perform other duties as assigned.

• HS Diploma Required, Degree preferred
• Pharmaceutical or Biotech GMP experience and Supplier Quality
• MUST have experience in review and release of GMP batch documentation (a minimum of 2 years of work experience) in the pharma/biotech industries
• Effective interpersonal communication. Must have effective verbal and written communication skills. Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• TrackWise, SAP, Excel.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.