Posting ID: JP-002659628
This individual will be responsible for validation of manufacturing processes, recommendation and implementation of process improvements, quality data analysis, and employing effective corrective actions for continuous improvement solutions. They will be based more on the quality of the process. How they clean the equipment, how they qualify the products, the manufacturing process. Process validation is a must. Aseptic manufacturing experience is critical. QMS experience, trackwise, master control, LIMS, open labs, empower 3. Auditing experience. Also being familiar with Minitabs, Pivot Tables. They will be keeping for the organization in prep for the quality management review. How they are trending and tracking on CAPA, investigations, deviations, NCRs. Right now this position is thought as a stepping stone into management in the future. Master Batch production records experience helpful as well. Other job duties will include: The Quality Engineer must be familiar with applicable cGMP regulations and systems Write and execute process validation studies (eg, product, cleaning, sterilization, media fills) Establish Standard Operating Procedures Perform investigation of product nonconformance's, conduct root cause analysis in accordance with internal procedures Create, generate, analyze, and report quality metrics throughout all levels of the organization to drive continuous improvement by using statistical tool methodology. In addition, must demonstrate the ability to apply statistical tools to define sampling strategies (i.e. six-sigma, etc.). Assist in training and maintenance of the site Quality Management Systems Audit critical manufacturing processes to ensure cGMP compliance and approve critical manufacturing areas for use. Assist in product recalls. Performs tasks/deviations/investigations/protocols/CAPAs of moderate and high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions. Responsible the timely closure of investigations. Partner with cross-functional team members to address and resolve quality issues; ensure appropriate training, processes and equipment are in place for all manufactured products. Write/execute/review/approve risk assessment
quality assurance, validation, aseptic, pharmaceutical
Top Skills Details:
Additional Skills & Qualifications:
3 years Quality Engineering or Quality Assurance 3 years experience in Pharma manufacturing Experience with process validation - PPQ Aseptic manufacturing experience required
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Recruiter: Jean Chambers
Phone: (410) 579-3072