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
• Maintain confidentiality
• Coaching skills

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Bethlehem, PA 18017: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person

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