QA Specialist II

Job Description:

• 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 Responsibilities:

• 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.

• Associate's degree in Life Science
• A combination of education and years of experience will be considered.

• Demonstrates an ability and desire to learn from experience
• Treats errors as a learning opportunity
• Demonstrates an openness to trying new approaches
• Supports a culture of process improvement and problem solving

• Understands the impact of his/her own actions on his/her business area
• Uses knowledge of his/her business area to make accurate and timely decisions
• Expresses ideas that will improve his/her business area

• Works as an active member of his/her team
• Generously shares information and knowledge with others on team
• Demonstrates an openness to different perspectives by balancing listening and speaking

• Understands what internal and/or external customers need from him/her to deliver in his/her respective role
• Takes action to enhance customer satisfaction within the scope of his/her role

• Consistently delivers goals while monitoring KPIs with supervisor
• Ensures quality standards are maintained while delivering results
• Plans, prioritizes and organizes work to deliver on time

• Acts as a reliable and dependable member of the team
• Seeks feedback and reflects on his/her development needs in order to
• continuously improve
• Takes responsibility for personal choices and behaviors

• 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

• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
• Must comply with safety policies of the company and site.

• Adherence to cGMPs is required at all times during the manufacture of APIs.
• All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.