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Job Summary:

The QA Specialist will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes 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, while ensuring 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
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process
Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
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
Provide training on department specific procedures and systems
Interface with clients to address any documentation and compliance concerns
Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable

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 3-5 years of pharmaceutical or biotech industry experience with 2+ 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 and 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 and Contacts

Cross functional staff, members of management, internal and external clients, members of the Quality organization

Managerial and Supervisory Responsibilities

No managerial responsibilities. This is an individual contributor role.

Travel

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