The primary responsibility of the Temporary Quality Assurance Lot Review Specialist is the review and closeout of all production batch documentation prior to release. Documentation includes manufacturing batch records and ancillary documentation such as Lot Genealogy Reports, and QC assays used in the production of Active Pharmaceutical Ingredients (API). The Quality Lot Review Specialist I makes decisions regarding routine tasks that arise during review of records and escalates to senior members of the team for complex issues; develops a skill set appropriate to the level that includes understanding quality systems, manufacturing practices, Good Documentation Practices, as well as effective communication and listening.
** This is a contract position that will go for four to six months with the possibility of extending**
** This is a day shift Monday - Friday normal business hours role **
- Independent Review and Closure of Manufacturing Batch Records and ancillary documentation to support the release of API.
- Review will be performed independently with minimal direction for the review process.
- Less complex record types will be the starting point of training qualification. Minimal manufacturing process knowledge is required at this level.
- Simple issues found during the review of documentation should be managed at this level to include identification of documentation errors. The Specialist can identify when a nonconformance has occurred, but may not understand GMP implications and appropriate actions to take without first obtaining feedback from a higher level Specialist. These issues are escalated to senior quality specialists or supervisors for mentoring through the process to gain the information required to make the appropriate decision.
- Quality decision-making accounts for routine activities that result from batch review.
- Participate in routine meetings as assigned by management
- Starts to develop skills that include an understanding of quality systems, basic biologics manufacturing, Good Documentation Practices, communication and listening
- Support Daily Management System and departmental tasks as assigned
- Bachelor’s Degree or Associates Degree with equivalent experience- preferred area of study: Science or Engineering background preferred
- Experience entry level years in GMP environment preferred
- Biopharmaceutical manufacturing background is preferred
- Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; some knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
- Skills- Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are a plus
- Qualities & Attitude - Motivated individual who has an attention to detail. Adaptable to changing priorities and reprioritization of workload. Works effectively individually and with teams with direction as required.
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