What are the responsibilities and job description for the QA Associate 1 position at Alltech Consulting Services Inc?
Job Description : I. Position Overview : 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 Company's SOP) through document review / approval, real time monitoring / approval of manufacturing activities and testing / approval of in-process and finished product samples. II. Specific Tasks, Duties and Responsibilities : 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 Company's 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
