Quality Assurance Associate
Quality Assurance Associate
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 Assurance Associate
- Location: Winchester, KY
- Industry: Pharmaceutical
- Hours: 5:45pm - 6am Mon, Tues, Wed, & every other Thurs
- Salary: $18.50hr (Paid Weekly - Benefits Available)
- Employment Type: Long Term Contract to Hire
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. 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, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
Job Performance Expectations:
- Recommend SOP and batch record changes as needed Review proposed SOP revisions and provide feedback to management Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters Perform room and equipment clearances per procedure following cleaning conducted by production.
- Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
- Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
- 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.
- Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards) 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
- Monitor compliance to DEA requirements related to the manufacture, storage and handling of controlled substances III.
Minimum Education and Experience:
(Minimum required to perform job) Preferred - Bachelor s Degree in related science or technical field in combination with 2 years prior relevant work experience. Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment. Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications