QA Associate

SAFC Biosciences has a long history in the cell culture products and reagents industry, spanning three decades, under different names. Customers have been a focus throughout our history, just as developing and manufacturing cell culture products such as animal sera, dry powder media, liquid media and supplements have been. Product development activities continue to expand our portfolio of serum-free media for use with a diverse range of cell lines. Customers and progressive products and services remain our focus today.

Primary purpose: Plan, administer, monitor and perform Quality Assurance activities within the assigned facility.

Sample, review and release raw materials in a timely manner, assuring any lot deviations are completed and closed.
Label approval, label generation, and review of daily QA paperwork to include charts, monitoring exhibits, and environmental records.
Review batch records prior to production.
Review and release finished products in a timely manner, assuring any lot deviations are completed and closed.
Execute timely investigations or review of TIS logs, verifying corrective and preventive actions have been taken and documented.
Participate in customer and ISO audits including opening meetings, tours, document review and any follow-up activities, as necessary.
Perform audits of suppliers as required by SAFC Biosciences policies. Inform suppliers of audit observations and any follow-up activities as necessary.
Conduct periodic internal audits to meet regulatory requirements on a regular basis.
Approve master batch records and batch records, assuring accuracy and completeness. Resolve any discrepancies in documentation.
Review and approve SAFC Biosciences product and customer product specifications.
Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations.
Performs other job related duties as may be required.

SAFC Biosciences is an equal opportunity employer. Applicants receive consideration for employment without regard to race, color, religion, sex, age, national origin, or disability. SAFC Biosciences offers a comprehensive and competitive Benefits Package. REQUIREMENTS
Qualified Candidates Must Have:
-Bachelor’s Degree in life sciences with a minimum of 2 years related experience or an equivalent combination of education and experience.
-An understanding of commercial Quality systems and the application of them in a manufacturing environment.
-Effective oral and written communication skills.
-Good customer service skills and the ability to negotiate win-win outcomes.
-Previous experience as an auditor of supplier products and services.

Preferred Qualifications:
-More than 2 years experience in a regulated industry with demonstratable familiarity with cGMP’s, cGLP’s and/or related FDA/ISO requirements.
-Quality Auditor Certification or the ability to obtain certification.