Job description

Quality Assurance Associate / Sanitation Supervisor

Job Classification: Exempt Supervisor: Director - QA/QC
Management Level: Skilled Pay Grade: Salary

JOB SUMMARY:

The QA Associate / Sanitation Supervisor will allocate their time between supervision of low complexity, facility sanitation procedures and performance of GMP Quality Assurance activities to ensure facility compliance with corporate, ISO and regulatory (21CFR Parts 111, 211, 820) standards.

Responsibilities - Sanitation

▪ Serve as the Sanitation Supervisor (master sanitation schedule, oversight of sanitation activities and cleaning logs).

▪ Author and implement HARPC plans.

▪ Author and revise SSOP’s.

▪ Train employees on SSOP’s.

▪ Perform ATP testing.

▪ Monitor and document performance of 3rd party pest control provider.

▪ Plan, perform, report and follow-up on sanitation and food safety internal and external audits.

▪ Foster and sustain a food safety culture.

Responsibilities - QA

▪ Support and perform QA activities as assigned including: calibration, change control, complaint response, incoming inspection, logbooks, periodic review, preventative maintenance and sampling plans.

▪ Train employees on SOP’s.

▪ Author investigations for nonconformances.

▪ Conduct root cause analysis and integrate into CAPA.

▪ Investigate customer complaints.

▪ Recognize and report, to the Quality Director, potential and actual: defects, deviations, and non- conformances.

▪ Provide the Quality Director with input / feedback on which to base Quality actions.

▪ Foster and sustain a Quality culture.

Education Requirement

▪ Bachelor's degree in a technical or scientific discipline preferred.

Experience Requirement

▪ 3-5 years Quality Assurance GMP experience (drugs / food / devices / supplements).

▪ 1-2 years Industrial Sanitation experience

▪ OR > 8 years’ experience in Quality or Sanitation management.

Competence Requirements

▪ Must be fully fluent (read/speak/write) in English / Spanish.

▪ Strong technical writing skills. A writing sample may be required.

▪ Strong communication skills with the ability to effectively communicate across departments.

▪ Able to accomplish defined goals and work with minimal supervision.

▪ A self-motivated, positive attitude, team-player that consistently goes above and beyond.

▪ Ability to deliver effective training (orally/presentations) is a plus.

▪ Ability to use Control charts, risk assessments, and statistics is a plus.

Physical Demands

▪ Can lift up to 25 lbs. Able to stand for prolonged periods of time. Able to wear PPE.

Job Type: Full-time

Pay: $62,400.00 - $83,200.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday
• No nights

Ability to commute/relocate:

• Paterson, NJ 07524: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Required)

Work Location: In person

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