Job description

Title: Technician – QA Documentation Control

Reports to: Supervisor – QA Document Control

Department: Quality Assurance – Product Release

Supervises: N/A

Organizational Relationships:

Direct interaction with analytical, microbiology, and quality laboratory personnel, quality inspection, specification, validation, and ADR personnel. Also interacts with Business Development Representatives, customer contacts, planning, and all operation personnel.

Basic Function:

Assures the pharmaceutical product documentation is maintained in compliance with the Food & Drug Administration regulations, 21 CFR, Parts 210 & 211.

Responsibilities:

1. Prepares, assembles, and reviews the records of both cosmetic and pharmaceutical product manufacture and packaging for regulatory audits.

2. Itemizes deficiencies and communicates deficiencies to appropriate personnel.

3. Follows-up on corrective action for timely disposition of bulk and finished goods.

4. Review and data correlation of product test results for release of bulk for filling, WIP for packaging, finished goods for shipment. Data is sourced from analytical, quality, microbiology, inspection, customer contacts and outside testing laboratories.

5. Assigns batch codes and sets expiry dates on bulk and finished goods – based on kdc/one/Customer policies and customer portal systems.

6. Effects disposition of cosmetic products on QAD system. Process entails: Change status of bulk—inspect, approve, and reject; Verify manufacturing transfer weight data; Verify and report packaging yield data; Effect positive release of finished goods.

7. The position requires defining BatchPak formulation associations with manufacturing procedures, remelt and mold procedures, bulk specifications, and finished goods specifications.

8. Executes Micro Exception requests by customer representatives per the customer.

9. Submission of bulk “OFA” samples to customer or outside lab for approval /test results. Position requires good customer service skills in that OFA samples must be tracked—numerous phone calls and e-mails must be made to the customer or outside labs. OFA response is then communicated internally for batch scheduling, remediation and/or disposition.

10. Manages the documentation customers require on OTC products.

11. Compiles the master batch packet for OTC products and maintenance of same for customer audits and regulatory inspections.

12. Compiles, maintains, and reviews the batch production record packet for OTC products in compliance to current good manufacturing practices.

13. Any other special projects and duties at the discretion of the supervisor.

Qualifications:

1. High School Diploma and 1-2 years relevant experience

2. Ability to read and write English

3. Ability to follow written instruction

4. Effective communication skills (Customer interaction)

5. Effective basic mathematic skill

6. Good organizational skills

7. Working knowledge of current good manufacturing practices (cGMP).

8. Working knowledge of kdc/one procedures as pertains to cGMP compliance.

9. Full knowledge of batch coding procedures (kdc/one and Customer) used to code bulk and/or finished goods.

10. Effective computer skills in Microsoft Word, Excel and BatchPak, QAD.

11. Working knowledge of minimum legal fill of container requirements.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• Port Jervis, NY 12771: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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