What are the responsibilities and job description for the Quality Assurance Associate position at Pharma Resource Group, Inc.?
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
- 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
III. Essential Skills and Experience:
Education or Experience:
- 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.
- Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.
Knowledge/Skills Requirements:
- Familiarity with basic laboratory instrumentation
- Safe work habits
- Basic math and computer skills
- Good communication skills
- Ability to follow written and verbal instructions
- Able to work with limited supervision for routine tasks
- Excellent documentation and handwriting skills
- Proficient reading and comprehension skills
- Sound decision-making, technical and problem-solving skills
- Good time management skills
- Expert technical writing and problem-solving skills
- Good Laboratory Practices
- Experienced with continuous improvement techniques
Job Type: Temp-to-hire
Pay: $22.00 - $26.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
- Night shift
Education:
- Bachelor's (Preferred)
Experience:
- CGMP: 2 years (Preferred)
- CAPA: 2 years (Preferred)
Location:
- Winchester, KY (Preferred)
Shift availability:
- Night Shift (Required)
Ability to Commute:
- Winchester, KY (Required)
Work Location: On the road
Salary : $22 - $26
