Quality Assurance Associate

SHIFT - FRI, SAT, SUN 6PM - 6AM

• 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 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.
• 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.
• Promotes teamwork and good communication.
• Minimum education and experience required to perform the job:
  • Bachelors degree; OR
  • Associates with 1 year of related work experience; OR
  • High School Diploma/GED with 2 years of related work experience

With almost four decades of experience as a proven industry leader, Acro continues to be consistently recognized among the Best & Brightest Companies to Work for in the United States. As an international professional services firm with deep expertise in consulting and staff augmentation offering a variety of solutions including MSP, VMS, RPO, HRO (and more), Acro operates across North America, Europe, and Asia from over 30 locations. Acro’s client portfolio includes some of the most well-known names in business and provides services across all verticals including technology, aerospace, energy, automotive, government, and manufacturing. To learn more, please visit www.acrocorp.com.