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QA Batch Record Specialist

2 months ago

Piedmont, United States PL Developments Full time
Work schedule: Monday - Thursday 4p - 2:30a

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


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