QA Batch Record Specialist - 3rd Shift

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

JOB SUMMARY:

QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release.

Work schedule: Sunday - Thursday 10:00pm - 6:30am

JOB QUALIFICATIONS:

• High School diploma or GED required; higher learning certifications in an area relevant to role preferred.
• Minimum one (1) year of experience in a FDA-regulated manufacturing facility.
• Ability to read and interpret documents in English.
• Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria.
• Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred.
• Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines.
• Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands.
• Ability to work both independently and as a member of a team.
• Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums.

POSITION RESPONSIBILITIES:

• Maintain professional, respectful and positive work environment.
• Practice acute attention to detail, high level of organization, and error-free performance in all tasks while supporting a fast-paced environment and adapting to changing priorities to meet operations demands.
• Generate controlled documents (e.g., logbooks, bulk compounding batch records, finished good batch records) for issuance using the Warehouse Management System (i.e., Oracle) and/or Quality Management System (i.e., Agile) as per the current production schedule and/or requests.
• Document transactions related to controlled document issuance, remittance, review, and release in shared logbooks and trackers as required.
• Document metrics related to processing batch records for release in shared tracker as required.
• Communicate with other departments regarding document control activities to ensure timely completion of tasks to support operations and release of finished goods.
• Review controlled documents (primarily batch records) returned/submitted to Document Control for completeness and correctness to ensure compliance with internal and regulatory criteria; facilitate resolution of observations (e.g., corrections) before release of finished goods and archival of documents.
• Place and remove product on QA hold when required; ensure Quality Events are resolved and verify disposition to manage bulk and finished goods accordingly.
• Change product status and close jobs in Warehouse Management System for release of finished goods.
• Upload required documents (e.g., batch records, customer-required documents) to appropriate shared file locations as required.
• Maintain the filing system for controlled document archival and destruction as per standard processes; retrieve controlled documents as requested for inspection.
• Assist with batch-related investigations as requested.
• Responsible for training employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category.
• Other reasonable business-related duties as necessary.

PHYSICAL REQUIREMENTS:

• Ability to lift up to 25 pounds.
• Adequate vision to read controlled documents accurately.

BENEFITS:

PLD is a proud equal opportunity employer offering many corporate benefits, including:

• Medical and Dental Benefits
• 401K wirh employer match
• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• Tuition Assistance
• Corporate Discount Program
• Opportunities to Flourish Within the Company

PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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