QA Administrator

JOB OVERVIEW

Multi-Pak Packaging is a trusted partner to leading companies in the healthcare industry. We provide clients with labeling and packaging options as well as comprehensive supply chain solutions.

Under the direction of the Director of Quality Control, the QA Admin that products adhere to a defined set of quality standards and meet the requirements of customers.

This position is primarily responsible for assisting the Quality Documentation Specialist in the administration and management of all quality documentation in accordance with the company’s SOPs to support production. The incumbent is also required to possess strong computer skills, write well, and have good interpersonal communication skills.

RESPONSIBILITIES:

• Ensure Batch Records are properly filed, secured, and controlled and easily retrievable in the quality department.

• Daily Review of Production Schedule and retrieval of closed batch records

• Responsible for the receipt, scanning and electronic filing of all Receiving Reports and COA/COC.

• Management of physical filing and archiving all documents related to QA Documentation department.

• Assist in reviewing Logbooks and retrieving documents during Audit.

• Review and verify the receipt of New Product Evaluation form including Stability Documents, COA, and Receiving Reports

• Create and verifies Shipper labels.

• Issue approved Batch Records (PO Specific) to Quality Office prior to production

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• Backup and assist in all areas of Quality, on an as needed basis.

• Provide administrative / technical support to the Director of Quality and the Quality Team.

• Maintain relevant quality logs as needed.

• Perform other related duties as assigned.

• After production, verify accuracy and completeness of Batch Record

• Prepares Certificate of Conformance (COC) for the release of finished goods.

• Prepares Final Reconciliation

• Provide all requested and or required documentation to the shipping department.

• Provide all completed final reconciliation to inventory.

• Key person responsible for the review, and management of records this includes:

o Verification of accuracy and completeness of documents to ensure cGMP.

o Electronic scanning and physical archiving of Batch Records

• Assist and facilitate internal investigation / deviations associated with batch records.

• Assist in the management of Annual Product Review recording.

• Provide Client support and Email Completed Batch Records to select Clients.

• Backup and assist in all areas of Quality, on an as needed basis.

• May be asked to assume ad hoc responsibilities in support of Quality functions.

• Assist with FDA and other regulatory agency inspections as needed.

• Perform other related duties as assigned.

• Assist in MP annual inventory.

QUALIFICATION REQUIREMENTS:

• 1-3 years’ experience in a pharmaceutical and/or nutritional supplement industry.

• Bachelor’s degree in a technical field (preferred not required); Minimum of associates degree or working towards the completion in a field such as finance/ accounting, logistics and / or manufacturing.

• Demonstrated experience with review records. (Preferred not required).

• Strong knowledge of solid dose packaging and labeling and associated record review.

• Experience working with Contract Packaging Organizations. (Preferred not required).

• Must be self-motivated and able work independently but maintain a team-focused attitude.

• Knowledge of FDA CFR 210-211 cGMP regulations and guidelines and QA best practices. (Preferred not required).

• Excellent attention to detail and follow through and organizational skills.

• Ability to advocate a quality environment.

• Excellent verbal, written, and interpersonal communication skills.

• Excellent Word and Excel skills.

• Data Entry experience.

REPORTING RELATIONSHIP:

• Manager: Director of Quality Control

• Managerial Responsibility: None

PHYSICAL/MENTAL DEMANDS:

· Must be able to remain in the stationary position up to 80% of the time.

· The person in this position may need to frequently move about inside the office to access office machinery, filing cabinets, etc.

· The person in this position is required to communicate with all other departments and must be able to exchange accurate information in these circumstances.

x Non-Exempt

NOTE: No traveling is required in this position.

Job Type: Full-time

Pay: $20.00 - $21.50 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Salary : $20 - $22