Overview
Quality Assurance Specialist Jobs in Berkeley, CA at TekWissen ®
Title: Quality Assurance Specialist
Company: TekWissen ®
Location: Berkeley, CA
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.
