Quality Assurance Associate II

Quality Assurance Associate IIThe Quality Assurance Associate II performs documentation activities associated with manufacturing operations while ensuring compliance with GXP quality systems.ResponsibilitiesDocument Management Electronic Document Management System (EDMS) workflow coordinator for GMP documentation and other GxP documentation, as neededDocument formatting and reviewAttachment issuance support, that includes, but is not limited to, issuing and reconciling Batch Records, Solution Records and Validation Testing documentation and maintaining tracking tools, both hard copy and electronicAssignment of raw material part numbersSupport raw material and product releaseLabel generationMaintenance of label and ribbon inventory and scheduling annual maintenance of labeling machinesWrite/revise QA SOPs and reports, as related to document controlMaintain, scan and archive Quality Assurance documentationReport on Vendor Change Notifications to determine their effects, if any, on manufacturingResponsible for organizing and maintaining off-site storage shipments for Fall RiverTraining Program Support Perform internal training, including, but not limited to, off-site storage preparationMaintain training documentation including the hard copies and the electronic training files in SharePoint, as neededAssist with the annual audit of training filesAuditor Conduct annual documentation auditsSupport internal GMP auditsSupport external audit documentation requestsOther related job functions and QA support as neededQualificationsAssociate Degree with 2+ years GMP experience or 4+ years GMP experience without a degreeDocument Management experience in GMP environment preferredBroad knowledge of GMP and other GxP quality systems, policies, and regulationsStrong communication and organizational skillsProficiency using MS Office SuiteProficiency using an EDMSThe ability to multi-task and manage and prioritize workload in a proactive mannerThe ability to take initiative, maintain confidentiality, meet deadlines, and work independently and as part of a teamCompensation StatementThe expected base salary for this position is: $66413.00 to $86250.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach. Celldex