QA SPECIALIST II, OPERATIONS
JOB SUMMARY
The QA Specialist II, Operations will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role include Batch Record Review, Lot Disposition, and Quality System review. This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.
JOB DUTIES
- Perform review of batch documentation for release of internal and external clinical products/commercial products, ensure compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
- Review and approve master batch records for the timely initiation of GxP manufacturing activities
- Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
- Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
- Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
- Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
- Coordinate change control review meetings; monitor status of change controls and facilitate the approval process
- Perform risk assessments to comply with internal procedures and external guidelines
- Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
- Ensures site readiness for regulatory inspections
PROFESSIONAL SKILLS
- Exceptional organizational skills and attention to detail
- Ability to make risk-based decisions and resolve issues with minimal guidance
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Proficiency in MS Office including Word, Excel, Access and Visio
- Excellent verbal and written communication skills required
EXPERIENCE
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of laboratory and production equipment and IQ/OQ/PQ
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
EDUCATION
- Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
- ASQ certification preferred
QUALITIES
- Ability to work in a dynamic, fast paced work environment
- Honesty, integrity, respect and courtesy with all colleagues
- Creative with the ability to work with minimal supervision and balanced with independent thinking
- Resilient through operational and organizational change
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Frequent reading, writing, and verbal communication
- Must be able to travel between multiple local production facilities
- Able to translate ideas to actual concepts and processes
- Proven ability to manage multiple projects (duties) simultaneously
- Able to work in a highly complex environment with competing demands and priorities
COMMUNICATIONS & CONTACTS
- Cross functional staff, members of management, internal and external clients, members of the Quality organization
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
- No managerial responsibilities. This is an individual contributor role.
TRAVEL
- < 10%
