Batch Record Reviewer / Specialist

"#INDEED_A"

Duration: 6 months
Shift 8am - 4:30 PM

Position Summary:

• The primary responsibility of the Commercial Quality Assurance Distribution Center Quality Specialist is to ensure that all quality procedures and forms for manual aggregation of finished products are reviewed, meets requirements, and approve and release product from Quality holds from the Warehouse Management System to be allocated for orders.
• May provide QA guidance and direction to the DC Operations team on any of the aggregation lines during the aggregation activities.
• Reviews Aggregation records, Work Instructions and SOPs. Communicates to Company manufacturing/packaging site QA teams any issues discovered during aggregation activities.

Essential Duties & Responsibilities:

• Perform review of the aggregation record for accuracy, good documentation practices, adherence to local SOP’s and work instructions.
• Review temperature data for shipments to and from external vendors and notify Company sites of excursions.
• Randomly spot check/audit the manual aggregation assembly lines for adherence to procedures, check/review logbooks.
• Release system locks on approved Aggregated Pallets via warehouse management system (WMS).
• Follows Company Safety, Health, and Environmental policies and procedures.
• Other duties, as assigned, or as business needs require.

Position Requirements:

• Education/Certification/Experience: Undergraduate/BA/BS degree in applicable discipline and 1-3 years of related experience. Years of experience on the job may substitute for a degree. Previous Quality Batch Record review experience preferred.
• Job-specific Competencies: Competencies that are necessary for the incumbent to do this position and that distinguish it from others similar to it.
• Advanced Skills and Ability to clearly speak (and understand) English Language in verbal and written form is required to perform the job. Customer Service/Customer Satisfaction skills and abilities are required to perform the job. Ability to multitask multiple activities. Ability to walk periodically, into large warehouse space to inspect or sample product or obtain paperwork and or discussions with DC operations personnel.
• Training is required in the Code of Federal Regulations, Current Good Manufacturing Practices, Company Policies and Procedures; Good Documentation Practices; Deviations/Investigations/Root Cause Analysis, CAPA; Data Integrity, TrackWise; MS-EXCEL, MS-Word, SAP, Manhatten Warehouse Management System a plus.
• Demonstrates the ability to work with minimum supervision

Physical Requirements: Frequently required to walk. Must wear safety shoes during work. Company has loaners (slip over existing shoes) here, or a pair can be ordered for candidate.

Job Types: Contract, Temporary

Salary: $35.00 - $42.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• North Wales, PA 19454: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Batch record: 3 years (Required)
• Document review: 3 years (Required)
• Quality assurance: 3 years (Required)

Work Location: One location

Salary : $35 - $42