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Sr QA Associate I

1 month ago

Wilmington, United States Alkermes Full time

Senior QA Associate I This function is responsible for final review of batch records prior to disposition of product and/or final approval for disposition of product. This position is also responsible for disposition and throughput of Raw Materials and Intermediate product. Functions include preparation and/or approval of batch Certificates of Analysis, document review and approval, material specification review and approval, TrackWise reporting, hold forms, discrepancy tracking and approval, change control review and approval, cross-departmental problem solving, project support. The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks. This function supports and communicates events to manager on a daily basis. Key Duties: Evaluation of batch manufacturing records and testing records Disposition of raw materials and bulk batches per associated specifications Final review of batch records and generation of documents for finished product disposition Final approval of Certificate of Analysis and batch disposition Review and approval of incident, Minor, and Major workflow deviations in Trackwise as the Quality Contact. Review and close of Corrective and Preventive Actions in Trackwise as the Quality Contact. Review and approval of Change Controls. Review and approval of Raw Material and Finished Product Specifications. Authority to approve written procedures and other documents Develop Standard Operating Procedures and other quality related documents. Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions Interact with plant personnel to insure CGMP compliance. Provides back up for other QA and plant site personnel as appropriate. The monitoring of compliance with the requirement of GMP Preferred Skills/ Abilities: Experience in team environment Working knowledge of US Drug Product GMP requirements and associated guidelines Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues Ability to increase others knowledge of US end European GMP regulations and guidance Strong written and oral communication skills Experience in administration of quality systems for drug product manufacturing and quality control operations Experience with SAP system Experience with reviewing and approving deviations at a minimum Experience following and developing Standard Operating Procedures Experience reviewing and assessing change controls Preferred Personal Attributes: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change Can manage multiple duties and tasks Ability to utilize knowledge and interpersonal skills to provide leadership Ability to problem solve across departments Source for development of others Good computer skills Good work ethic, dependable, punctual, and flexible Good motivator of personnel Good team player with a can-do attitude Can get things done on the basis of influence Can work in a fast-paced environ