What are the responsibilities and job description for the Lead QA Batch Record Reviewer position at PL Developments?
PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.
A QA Batch Record Reviewer is responsible for ensuring the accuracy, completeness, and compliance of manufacturing batch records. The primary duties include reviewing
documentation related to the production process, verifying adherence to standard operating procedures (SOPs) and regulatory requirements, and identifying any discrepancies or deviations. QA Batch Record Reviewers collaborate with production teams to address issues, provide feedback on documentation improvements, and ensure that products meet quality standards. Strong attention to detail, knowledge of relevant regulations, and effective communication skills are essential for success in this role.
Work schedule: Monday - Thursday 5:30a to 4p
JOB QUALIFICATIONS:
- Education: High School diploma or GED required; Associate degree preferred
- Experience: Minimum three (3) years of experience in GMP manufacturing environment; pharmaceutical experience preferred
- Language: Ability to read and interpret documents in the English language
- Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to use PC, calculator, and basic software (Microsoft Office); GMP software experience preferred
- Ability to read and follow cGMP, SOP and Safety guidelines
- Must be able to work in a fast-paced environment
- Must be detail-oriented
- Must have excellent communication skills across all levels
POSITION RESPONSIBILITIES:
- Review and resolve open work orders in collaboration with QA Management and other departments, as necessary
- Train new QA Batch Record Reviewer employees on the responsibilities and processes to perform required tasks
- Calculate batch-related metrics and communicate at a determined frequency
- Provide updates to QA Management regarding challenges preventing batch release as related to Reviewer responsibilities
- Facilitate resolution of batch-related issues through communication and collaboration with other departments and PLD sites as necessary
- Ensure internal trackers for documentation and projects are maintained as instructed by Document Control Supervisor and perform periodic review for suspicious items
- Ensure filing system is maintained by Document Control Personnel
- Oversee annual batch record archival is completed by Document Control Personnel
- Review production and laboratory-related batch paperwork to ensure compliance
- Change product status in the material management system and release finished goods
- Place and remove product on QA hold when required
- Confirm completion of batch-related investigations
- Retrieve, file, scan, and archive batch-related documents
- Assist with batch-related investigations as needed
- Other reasonable business-related duties as necessary
PHYSICAL REQUIREMENTS:
- Periodically stand and walk
- Ability to lift 10 pounds and occasionally push / pull / lift 25 pounds
- Adequate vision to accurately read numbers and batch paperwork
BENEFIT OVERVIEW:
PLD is a proud equal opportunity employer offering many corporate benefits, including:
• Medical and Dental Benefits
• 401K
• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• Tuition Assistance
• Corporate Discount Program
• Opportunities to Flourish Within the Company
