Quality Assurance Compliance Specialist

Essential Duties and Responsibilities

• Packaging Batch Records: Reviews final batch records on paper and electronically, documents batch errors from various departments, tracks, and issues reports.

• Manufacturing Batch Records: issues batch records to production, electronically review production batch records, file and archive all the completed physical records.

• Review lab data on paper/electronically for inclusion on C of A

• Responsible for certificate of acceptance (C of A) generation for Bulk and Finished drug product, coordination of finished batch status tracking

• Releases product within SAP and generates reports as needed

• Reviews calibration sheets.

• Supports the quality document archive system

• Assist in the activities related to document control when needed

• Act as a backup to other QA associates in his/her absence

• Performs and supports internal audits and regulatory agency audits as needed

• Performs special projects as directed by Quality Assurance management

• Trains new employees in the department on the various tasks

• Supports launch of new products in auditing/ understanding new processes as needed

• Assist with reviews and investigations for Deviations

• Assist with and/or conduct APRs

• Assist with and/or conduct the updating of CRNs

• Produce logbooks as requested

• Supports RA requests relative to filings and submissions

• Support Packaging Line Inspector including coverage as needed

• Assist with and/or conduct BOM and MBR updates

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems

• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers

• Excellent verbal and written communication skills

• Creative and able to present various solutions

• Energetic, enthusiastic and motivational disposition

• Maintain confidentiality

• Coaching skills