Quality Analyst I Must be able to work a 4/10 day which may include a split shift schedule. One weekend day would be required. Job Summary
Responsible for performing the day-to-day quality operations (QA Inspection) for QA Filling/Finishing within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines and the client's quality practices. Job Responsibilities
Education & Qualifications
- Responsible for QA Inspection activities associated with Aseptic Filling, Capping, Packaging and Label Management.
- Conduct JD Edwards (JDE) transactions for inventory management, as well as, product status updates.
- Support product complaint investigations.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
- Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc. Support process with timely closure of observations/ audit items.
- Revise or review standard operating procedures (SOP's).
- Participate in process improvement projects.
- Responsible for batch record review. Ensure that all steps have been documented and verified. Ensure processes are performed within applicable limits relating to departmental SOP's. Ensure that all appropriate testing meets specifications.
- May perform other duties as assigned.
- Associate degree in a scientific discipline and one to three years of relevant experience within most recent 5 years or an equivalent combination of education and experience.
- Bachelor's degree in the life sciences, business or other technical field preferred.
- Experience in biotech industry within Filling/Finishing areas desirable.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving, and good verbal and written communication skills.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and Application of Good Manufacturing Practices.
- Must be able to work in controlled clean room environment requiring special gowning. Requirements include: no jewelry or cosmetics. Special gowning requires complete coverage of head, face, hands, feet and body.
- Personal protective equipment must be worn due to safety requirements.
- Overtime may include weekends and holidays.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.