QA MFG Associate I

Now Hiring for QA Manufacturing Associate I. This role is a evening shift from 1PM-9

PM 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 c

GMP, 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.