Quality Operations Specialist
Malvern, PA US
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Quality Operations Specialist
- Location: Malvern, PA
- Industry: Pharmaceutical
- Hours: 2:00pm 10:30pm Mon-Th (onsite)
- Salary: $37hr (Paid Weekly - Benefits Available)
- Employment Type: Contract with the potential for direct hire
The QA Associate is responsible for the Quality support functions associated with the manufacturing. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval and real time monitoring/approval of manufacturing activities.
Review proposed SOP revisions and provide feedback to management / Recommend SOP and batch record changes as needed
Real-time audit of batch records in the production for completeness, documentation, calculation errors and conformance to critical process parameters
Perform room and equipment clearances per procedure following cleaning conducted by production.
Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to manufacturing.
Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
Other assignments as needed within the scope of QA Associate training curriculum.
Assist in investigations for deviations by supporting data gathering and root cause analysis
Enforcement of GMP Compliance.
Promotes team work and good communication.
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Supports customer complaint investigation by performing inspection of retains and complaint samples
- Bachelor s Degree in related science or technical field preferred with 2 years prior work experience
- Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
- Bachelor s degree or higher 4-6 years in a regulated environment. 3+ years administrative leading a team.
- Must have prior QA in a regulated environment