Quality Assurance Specialist I
San Mateo, CA 94404 US
Target PR Range: 35-45
*Depending on experience
The Quality Assurance Specialist I will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and quality practices.
Responsibilities (include but are not limited to):
- Disposition raw materials globally for manufacturing network
- Review material related documentation and ensure resolution of issues to release material
- Manage Pharma Quality Systems for Global Raw Materials and Reagents group
- Provide quality oversight for the QC lab for raw material testing
- Execute Quality walk through for QC Lab for raw material testing
- Review batch-related documentation and ensure resolution of issues to release product
- Oversee material qualification process, approve material qualification protocols, reports
- Oversee material specification lifecycle process, approve specification initiation, changes and obsolescence.
- Manage Change Control system and ensure proper maintenance and approval of cGMP documents.
- Ensures change controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Manage the Deviation and CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
- Conduct effective root cause analysis and implement corrective action and preventative action.
- Host/support regulatory inspections, internal audits, and external audits from partners.
- Review technical/ investigation reports as appropriate.
- Review and approve proposed changes to systems, and procedures.
- Provide QA guidance to material development projects and technical transfer activities.
- Provide data for Quality related metrics
- Ensure all material-related Deviations and CAPAs are initiated, investigated and resolved, as needed.
- Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
- Up to 10% domestic travel
- Perform duties as needed
- Masters Degree and 5+ years experience in cGMP regulations, quality systems and regulatory
- Bachelors Degree and 7+ years experience in cGMP regulations, quality systems and regulatory
- High School Degree and 11+ years experience in cGMP regulations, quality systems and regulatory requirements
- Degree in the biological sciences or related field
- Direct management/leadership experience in a pharmaceutical or biologics operation.
- Experience in identifying, writing, evaluating and closing CAPAs.
- Experience with conducting and managing internal and external audits.
- Strong knowledge of change control practices/strategies.
- Proficient in MS Word, Excel, Power Point and other applications.
- Ability to effectively negotiate and build collaboration amongst individuals.
- Demonstrated ability to develop, coach, and mentor key employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Preferred: ASQ, Black Belt/Green Belt certifications.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.