Quality Assurance Compliance Specialist

Quality Assurance Compliance Specialist

Are you looking for a role that will allow you to gain exposure and experience in various aspects of Quality Assurance? This role will be gain experience working with document control review, batch record review, as well as participating in audits.

Our client, a global leader in the development and manufacturing of inhaled anesthetics, is looking for a Quality Assurance Compliance Specialist to join their growing team and help support the manufacturing of their diverse commercial portfolio, while reporting to the Associate Director of Quality Assurance.

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

QUALIFICATIONS

Education/Experience

• Minimum of 4-year degree in science or technical field, preferably Chemistry or similar discipline (or combination of equivalent experience) preferred
• Minimum of 5 years’ experience in a regulated industry; Pharmaceutical or Medical device
• Knowledge of FDA, GMPs, GDPs, GLPs and Quality Assurance/Quality Control skills required
• Understanding of quality systems and processes
• Excellent verbal and written communication skills
• Experience with Microsoft Office applications and Trackwise systems (SAP and EDMS experience a plus)
• Experience within a manufacturing and/or packaging environment
• Demonstrated ability for effective communication, teamwork, and problem solving skills