QA Manufacturing Associate I/II/III

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:
Associate I level:

• A Bachelor’s Degree is required – Chemistry, Biology or other Life Science degree, preferred

Associate II/III level:

• A Bachelor’s Degree is required – Chemistry, Biology or other Life Science degree, preferred
• At least 3 years of work experience in a GMP (Good Manufacturing Practice) facility is preferred with good working knowledge of 21 CFR 210, 211, 699, Eudralex Volume 4 and related Annexes and ICH Q7 guidance.
• At least 3 years of experience working with/or approving/auditing executed 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 experience performing visual inspections for cleanliness is preferred.
• At least 3 years of experience with HPLC, performing integration and audit trail review for process conformance and GDP compliance is preferred.

General requirements for all levels:

• 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.
• Must be able to walk, sit or stand in a stationary position with or without assistance.
• Must be able to push, push or lift up to 20lbs
• 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
• Must be able to wear safety shoes & glasses throughout the day while in designated areas.
• You must be cleared by a physician and able to wear a respirator throughout the day while in designated areas.
• Must be ok working in a chemical environment.

Available Sites & Buildings

If you’re thinking about bringing your business to South Carolina’s Aiken, Edgefield, and Saluda region, we’re ready to accommodate you with a broad variety of existing facilities and ready-to-build sites.

Education

The highly skilled workforce in the Aiken, Saluda, McCormick, and Edgefield region is ready to meet the challenges of a rapidly changing economy because of the emphasis on education.