Job Title : QA Associate
Regular Hours (SHIFTS)
1. MON-FRI 6AM - 2:30PM.
2.FRI, SAT, SUN 6PM - 6AM.
3. FRI, SAT, SUN 6AM - 6PM.
Duration- 6 Months (Contract To Hire)
MAJOR DUTIES:
• 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.
• 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
Education Requirements
Education or 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.
...Job Description & Requirements Advanced Gastroenterologist StartDate: 8/4/2025 Available Shifts: M-F, split time between clinic and procedures; call of 1:4 Pay Rate: $600000.00 - $625000.00 Advance your career with a high-volume advanced GI role at a mission...
(Physician/MD qualifications required) Physical Medicine and Rehabilitation - Join our dynamic team as a Physiatrist rounding at leading Post Acute facilities in the Boston area! Enjoy the flexibility of creating your own schedule with a commitment of just 2 to 4 days per...
...Direct Sales Representative Java House continues to grow with the introduction of our Java House Liquid Beverage System. The ultimate... ...valid drivers license. Car allowance provided. Must be able to travel throughout assigned territory and other markets as needed...
Mine Engineer I - UndergroundRequisition ID: 138252Location:Phoenix, AZ, US, 85004-2121Category: Engineering ServicesShare this JobWhy You Should Apply For This Job:**Why You Should Apply for This Job**_At Freeport-McMoRan, we are committed to providing an employment...
...Job Description & Requirements Gastroenterologist StartDate: ASAP Available Shifts: Monday-Friday 8A-5P Pay Rate: $597996.00 - $597996.00 A large health system in Colorado seeks a BE/BC Gastroenterologist to join a well-rounded, established gastroenterology...