QA Batch Record Specialist - 1st Shift

Work schedule: Monday - Thursday 5:30am-4pm

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.

#HP1