QA Specialist - Portsmouth, NH

Job Title: QA Specialist II

Job Description:

Summary:

• The primary responsibility of the Quality Assurance Specialist II-Lot Review 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).
• Quality Assurance Lot Review Specialist II makes decisions regarding routine and some moderately
• complex issues that arise during review of records. Escalation to senior members of the operations team is employed for complex issues.
• Quality Assurance Lot Review Specialist II demonstrates understanding of quality systems, manufacturing practices, Good Documentation Practices, as well as effective communication and listening. Training of junior staff may be requested for certain tasks.

Key Accountabilities:

• Review and closure of manufacturing batch records and ancillary documentation to support the release of API.
• Review will be performed independently with minimal direction. Independent review of material documentation and interaction with internal customers for disposition of materials.
• Participation in routine meetings as assigned by management.
• Demonstrates skills that include understanding of quality systems, basic biologics manufacturing, Good Documentation practices, communication and listening.
• Apply Data Integrity principles in all aspects of work, in compliance with Client DI policies, guidelines and procedures.
• Supports daily management systems
• Perform other duties as assigned.

Skills:

• Knowledge of Microsoft Office Tools (Word, Excel, Outlook) is required; knowledge of cGMP preferred (ICH Q7a, CFR 210/211 CFR 820 etc.)
• Attention to detail and critical thinking skills are required; knowledge of Trackwise, SAP are preferred
• Motivated self-starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload.
• Works effectively individually and within a team environment with direction as required.
• Presents facts clearly and logically and understands other perspectives.
• Able to identify and act on situations that require escalation with / without guidance