Job Description
Job Description
Note:
Fully Onsite
12-hour shifts - Must have flexibility with shifts
6:00PM - 6:30 AM - May fluctuate over the duration of the contract
Ideal Candidate: B.S or relevant experience. GMP background is nice to have.
Nice to have: Veeva, Track wise, SAP, Maximo, and MES, Scientific experience / background
Job Details:
As Associate QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed. Next to that, you will provide support in different QA related projects/systems.
In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance, and engineering.
Basic Qualifications
High school/GED + 2 years’ work experience or Associates degree and 6 months’ work experience or bachelor’s degree
Top 3 Must Have Skill Sets:
GMP experience/exposure
Attention to Detail
Team Oriented
Day to Day Responsibilities:
Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Act as a first point of contact in case of production queries (quality related) during packaging and labelling operations.
Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
Perform finished product checks during (commercial) production runs
Compile and review batch records for lots assembled, packaged, and labelled in preparation for batch disposition.
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
Review and approve Deviation, CAPA, and Change Control records.
Adhering to safety rules and maintaining a safe work environment for both you and others