Compliance Specialist
Date Posted
12/6/22
Location
Bethlehem, PA
Position Id
1869
Degree Required
Job Type
Job Description
#1869 Quality Assurance Compliance Specialist
Essential Duties and Responsibilities
- Packaging Batch Records: issues batch records to packaging, reviews final batch records, documents batch errors from various departments, tracks, and issues reports
- Responsible for certificate of acceptance (C of A) generation for finished drug product, coordination of finished batch status tracking and batch release
- Releases product within SAP and generates reports
- Production Batch Records: issues batch records to production, review production batch records, file and archive all the completed records.
- Reviews calibration sheets.
- Monitors and provides trend analysis of DIs, LIs, CAPAs, customer complaints, and change controls
- Responsible for the quality document archive system
- Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases
- Assist in the activities related to document control when needed
- Assists in investigations as needed
- Act as a backup to other Compliance associate in his/her absence
- Performs and supports internal audits and regulatory agencies audit
- Supports launch of new products in auditing/ understanding new processes
- Performs special projects as directed by Quality Assurance management 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 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
- 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