Quality Assurance Specialist II

Position Title : QA Specialist II Operations

Location: Bedford, New Hampshire

Department: Quality Assurance

Responsible For (Staff): No

The QA Specialist II 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 product

• S:
  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 organizat
• ion Review and approve master batch records for the timely initiation of GxP manufacturing activit
• ies Responsible for quality oversight and administration of the deviation/investigation and CAPA progr
• ams Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP complia
• nce Provide direction for complex investigations and CA
• PAsEnsure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CA
• PAsReview, develop, and improve quality system procedures, specifications, and test meth
• ods Review and approve CAPAs to prevent recurrence of deviati
• ons Review and approve Change Control document at
• ion Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review proc
• ess 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 mann
• er.
  
  Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to managem
• ent Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvem
• ent 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 organizat
• ion Coordinate change control review meeti
• ngs Monitor status of change controls and faciliti ze the approval proc
• ess Perform risk assessments to comply with internal procedures and external guideli
• nes Provide training on department specific procedures and syst
• ems Interface with clients to address any documentation and compliance conce
• rns Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applica
• ble Ensures site readiness for regulatory inspecti

• ired:
  
  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 produ
• ction
  
  Experience performing RCA, technical writing, and working with quality related investiga
• tions
  
  Knowledge of laboratory and production equipment and IQ/
• OQ/PQKnowledge of FDA regulations (i.e., 21
  
  CFR Part 210, 211 & 820) and some experience working with international regulations such a
• s ICHExperience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with I

• ferred:
  
  ASQ certification preferred Exceptional organizational skills and attention to
• detail
  
  Ability to make risk based decisions and resolve issues with minimal g
• uidance
  
  Excellent interpersonal skills and the ability to communicate well orally and in
• writing
  
  Proficiency in MS Office including Word, Excel, Access an
• d Visio Excellent verbal and written communication skills r
• equired
  
  Ability to work in a dynamic, fast paced work envi
• ronment
  
  Honesty, integrity, respect and courtesy with all col
• leagues
  
  Creative with the ability to work with minimal supervision and balanced with independent t
• hinking
  
  Resilient through operational and organizational
• change
  
  Less than 10%
• travel.
  
  This position may require additional hours and/or weeken