Quality Assurance Associate

Responsibilities

• 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 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 in real-time
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements to identify and resolve routine errors and prevent possible deviations that affect production in real-time
• Work 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 can be conducted by the responsible department
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Enforcement of GMP compliance
• Promote teamwork and good communication
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Complete investigations of customer complaints

• Bachelors degree; OR
• Associate’s with 1 year of related work experience; OR
• High School Diploma/GED with 2 years of related work experience

$22.94-$22.94/hr

Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits; health savings accounts with qualified medical plan enrollment; 10 paid days off; 3 days paid bereavement leave; 401(k) plan participation with employer match; life and disability insurance; commuter benefits; dependent care flexible spending account; accident insurance; critical illness insurance; hospital indemnity insurance; accommodations and reimbursement for work travel;

and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement are provided based on state or local law.