Quality Assurance Specialist
Randstad is the #1 HR Services company in the world. We have an exciting and immediate position open for a Quality Assurance Specialist to work in Berkeley, CA. As the successful candidate for this position, you will provide technical support for clinical batch manufacturing which includes reviewing clinical batch production documents, providing QA evaluation of discrepancies, support implementation of respective global Quality initiatives, programs and regulations and share best practices experiences within Quality function. Our client for this position is one of the world's largest life science companies, focusing in healthcare, pharmaceutical and agricultural research. You must be available to work the graveyard shift.
Why Randstad? Randstad is a global leader in staffing. Randstad started in 1960 on the back of our founder Frits Goldschmeding's bike, and has since grown to be number one in the staffing industry globally.
Click to apply or send resume to email@example.com
Independently reviews, revises and approves clinical batch production documents (e.g. master batch records, Clinical Manufacture Facility's operational SOP, Change controls, Deviations etc.) and provides QA evaluation of discrepancies offering sound suggestions on improvement.
Trains internal customers/stakeholders on QAD relevant activities.
Supports internal and external inspections and audits.
Revises SOPs or other QA & Compliance documents.
Signs Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP).
Reviews and approves manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan.
Working hours: 8:00 AM - 5:00 PM
Proven ability as a team player.
Strong analytical and problems solving skills.
Ability to professionally express views and opinions.
Good listening skills and ability to accept conflicting point of views.
Strong verbal and written communication skills
Strong organizational skills with attention to detail
Ability to navigate different personality styles in a large, complex organization in a professional manner.
Ability to juggle multiple priorities.
Bachelors degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics.
6+ years of related experience in the biopharmaceutical industry with an emphasis in Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience.
4 years of relevant experience in the biopharmaceutical industry
with an emphasis in Clinical Manufacturing lot release in a GMP regulated industry.
Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs.
Previous work experience in a Clinical manufacturing setting
General understanding of drug development process R & D area
Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.
Proficiency in IT systems and software, e.g., MS Office and SAP
This is a great opportunity in a positive, innovative work environment where all workers are treated with respect and diversity is accepted.
Benefits provided by Randstad include medical, dental, vision insurance; 401k; and holiday pay.
Relocation cost reimbursement is not available for this position.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law. San Francisco Fair Chance Ordinance: Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.