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Quality Assurance Specialist

TekWissen
Berkeley, CA Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/3/2025

Job Title : Quality Assurance Specialist

Location : Berkeley, CA, 94710

Duration : 12 Months

Job Type : Contract

Work Type : Onsite

Pay Rate : $52-52 / hr.

Overview :

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.

Job Description :

  • Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records).
  • Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product.
  • Ability to provide technical guidance to production operators and management.
  • Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

Skills & Qualifications (education, experience) :

  • Bachelor’s degree in a scientific / technical field.
  • Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations.
  • A minimum of four years of direct experience in Manufacturing and / or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
  • Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process.
  • Previous work in Quality Assurance (e.g., release) preferred.
  • Proven ability as a team player and leader.
  • Excellent interpersonal skills
  • Must be able to listen and understand the opinions and
  • perspectives of others while influencing without authority with internal and external customers / stakeholders regarding possible recommendations.
  • Ability to work both independently and team environment.
  • The ability to multitask and support changing priorities
  • Strong written and oral communication skills
  • Ability to assess, investigate and resolve deviations.
  • Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
  • In depth knowledge of GMP

    • TekWissen® Group is an equal opportunity employer supporting workforce diversity.

    Salary : $52

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