Now Hiring for QA Manufacturing Associate I. This role is a evening shift from 1PM-9PM
Primary Responsibilities:
- On the floor monitoring of facility / production manufacturing suites for compliance to SOPs, cGMP, cGDP, batch record review, and identify and resolve routine errors and prevent possible deviations affecting real-time production. This includes documentation completeness, HPLC integration review, pooling designation review, managing calculation errors, deviations, and conformance to critical process parameters (CPP).
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Maintain a full understanding of all AmbioPharm SOPs and policies along with all cGMP, CFR, ICH guidelines applicable to the manufacturing of APIs.
- Work cross-functionally to assess impact for potential deviations and assist in identifying when an investigation is required.
- Promote teamwork and good communication.
- Provide training and coaching to manufacturing staff, as needed.
- Support site process improvements (training, efficiency projects, implementing of CAPAs).
- Initiate or coach deviations for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
- Perform incoming quality attribute inspections, review and disposition raw and in-process materials.
- Assist with label generation and reserve sample program.
- Recommend SOP and batch record changes, as needed.
- Assist in investigations for deviations by supporting data gathering and root cause analysis.
- Enforce GMP Compliance
- Review proposed SOP revisions and provide feedback to management.
- Other assignments as needed within the scope of QA Associate training curriculum.
- Complete investigations of customer complaints.
- Other responsibilities as assigned.
Qualifications:
- A Bachelor’s Degree is required - Chemistry, Biology, or other Life Science degree, preferred.
- Flexibility to work a non-traditional shift is required supporting second shift activities.
- Microsoft Office Suite proficiency is preferred; this includes Microsoft Outlook, Word, and Excel.
- Familiarity with HPLC, Empower, and 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
- Good Laboratory Practices and Good Documentation Practices
- Experience with continuous improvement techniques
- Demonstrate initiative.
ADA-These Requirements are a Condition of Employment:
- Must be able to push, pull, squat, stand and walk through-out the day.
- Must be able to lift up to 20lbs.
- Must be able to wear safety shoes & glasses throughout the day while in designated areas. (provided by the company)
- You must be cleared by a physician and able to wear a respirator throughout the day while in designated areas.
- You must be able to work in a chemical environment.
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