Quality Assurance Associate II:
The QA Associate II is responsible for the Quality support functions associated with the manufacturing of active pharmaceutical ingredients (APIs). The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, ICH, and AmbioPharm SOPs) through document review/approval, real-time monitoring/ approval of manufacturing activities and testing/approval of in-process and finished product samples.
Specific Duties and 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 AmbioPharm SOPs and policies along with all cGMP, CFR, ICH guidelines applicable to the manufacturing of APIs.
- 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 affecting real-time production.
- Work cross-functionally to assess impact for potential deviations and assist in identifying when an investigation is required.
- Initiate deviations for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
- 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
- Enforce GMP Compliance.
- Promote team work and good communication.
- Provide training and coaching to manufacturing staff as needed.
- Support site process improvements (training, efficiency projects, implementing of CAPAs)
- Complete investigations of customer complaints
- A Bachelor’s Degree is required.
- Biology or other Life Science degree is preferred.
- At least 3 years of work experience in a GMP (Good Manufacturing Practice) facility is preferred.
- At least 3 years of experience working with/or auditing batch records is preferred.
- At least 3 years of experience working with Standard Operating Procedures and associated documentation within a regulated industry is preferred.
- At least 3 years of technical writing experience is preferred.
- At least 3 years of experience performing visual inspections for cleanliness is preferred.
- At least 3 years of experience performing inspections for process conformance and complete documentation is preferred.
Flexibility to work a non-traditional shift is required
Microsoft Office Suite proficiency is preferred; this includes Microsoft Outlook, Word, and Excel.
- Familiarity with basic laboratory instrumentation
- Safe work habits
- Basic math and computer skills
- Good communication skills
- Ability to follow written and verbal instructions
- Ability 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
- Experience with continuous improvement techniques
- Demonstrate initiative