Job description

Title: QC Supervisor

Report Line: QC Manager

Shift Schedule:

• 1st shift (7am-4pm)
• 2nd shift (3pm-12am)
• 3rd shift (11pm-8am)

Must be able to commute to Somerset, NJ and Monroe Township, NJ

(Currently in Somerset but relocating to 7 Fitzgerald Ave., Monroe Township, NJ in August or September)

POSITION SUMMARY:

This position will be responsible for working with the Quality Control Manager to support daily activities related to the production of medical device products in accordance with Access Bio procedures and protocols, and in compliance with GMPs.

ESSENTIAL FUNCTIONS:

• Execution of line clearances (Rooms / Equipment) and verification of start-up activities and In-Process checks.
• Performs AQL Sampling and inspection of finished goods, perform appropriate material control in accordance with current specifications.
• Monitor and maintain cGMP activities at the plant including assembly, pouching, labeling and packaging activities.
• Ensure all production and QC testing data is recorded in real time in DHRs.
• Provide training to new associates according to the company SOPs as applicable.
• Responsible for stage release of all products (tagging) to production and inventory departments.
• Responsible for verifying all equipment being used for production related activities are in calibration.
• Perform data entry and supports trending analysis.
• Identify non-compliance problems and propose solutions as appropriate.
• Manage non-conforming material, label and segregate as needed.
• Support Internal Audit program and regulatory audits.
• Ensure that all data is organized and archived per appropriate workflows and SOPs.

QUALIFICATIONS:

• A minimum of High School diploma with 2-4 years of relevant experience in a GMP regulated Pharmaceutical/ Medical Device/Nutraceuticals industry.
• Good documentation skills.
• Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities
• Bilingual, Spanish, preferred but not necessary.

KNOWLEDGE, SKILLS AND ABILITIES:

• Detail-oriented and organized
• Ability to multi-task and be adaptable
• Must have the ability to work in a team-oriented environment
• Experience with using Microsoft Word and Excel

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Night shift
• Overtime
• Weekend availability

Work setting:

• In-person

Ability to commute/relocate:

• Township of Monroe, NJ 08831: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 2 years (Required)
• GMP regulated Pharmaceutical/ Medical Device/Nutraceuticals: 2 years (Required)

Shift availability:

• Day Shift (Required)
• Overnight Shift (Required)

Work Location: In person

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