QA Batch Record Specialist - 3rd Shift

PL Developments

About The Position

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. This role is responsible for reviewing and reconciling batch documentation following production runs, including the processing of returned records and components, to ensure accuracy, completeness, and compliance prior to product release. The position also plays a key role in supporting the transition from paper-based batch records to electronic batch records (EBR), ensuring data integrity, traceability, and adherence to internal quality standards and applicable regulations. Work schedule: Sunday - Thursday 10 pm - 6:30 am

Requirements

High School diploma or GED required; higher learning certifications in an area relevant to role preferred.
Minimum one (1) year of experience in an FDA-regulated manufacturing facility required.
Ability to read and interpret documents in the English language required.
Mathematical Skills: Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria required.
Ability to use PC, calculator, and basic software (i.e., Microsoft Office);
Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines required.
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 as required.
Ability to lift up to 25 pounds.
Adequate vision to read controlled documents accurately.

Nice To Haves

GMP software (e.g., Agile PLM, Oracle) experience preferred.
higher learning certifications in an area relevant to role preferred.

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.
Process returns for components, Reconciliation and enter labor hours after the job is completed in production area.
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 and electronic batch records (EBR), 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.
Train employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category.
Assist with batch-related investigations as requested.
Other reasonable business-related duties as necessary.