Associate, QA Operation Support

USPL NUTRITIONALS LLC • North Brunswick Township, NJ

97d

About The Position

This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 111 and 117.

Requirements

• B.Sc. / B.Pharm. or equivalent in a science-related field for Level 1.
• Relevant QA experience working within a GMP and/or with GCP regulations for Level 1.
• B.Sc. / B.Pharm. (required) and 1–3 years of experience in QA or related area preferred for Level 2.
• B.Sc. / B.Pharm. (minimum); M.Sc. / M.Pharm. preferred and 3–6 years of relevant QA experience working within a GMP and/or with GCP regulations for Level 3.

Nice To Haves

• Basic understanding of GMP (preferred) for Level 1.
• Working knowledge of cGMP and SOPs for Level 2.
• Strong knowledge of cGMP and quality systems for Level 3.

Responsibilities

• Assist with material sampling and dispensing under guidance.
• Support line clearance and hygiene compliance checks.
• Label and transport sampled materials as per SOPs.
• Maintain basic records and area cleanliness.
• Learn cGMP and SOP requirements.
• Execute material sampling, releasing, dispensing as per approved procedures as needed.
• Perform line clearance and ensure area readiness.
• Label materials correctly and ensure segregation of sampled vs. un-sampled.
• Maintain logbooks, records, and data entries accurately.
• Report deviations or incidents to the coordinator promptly.
• Supervise and coordinate QA sampling releasing, dispensing as per approved procedures as needed.
• Review documentation completed by associates.
• Ensure timely and compliant execution of sampling plans.
• Conduct training and mentoring for junior staff.
• Support audits, investigations, and CAPA implementation.
• Perform issuance of batch cards of Manufacturing, Coating and Packaging.
• Collect samples from on floor production for further testing and retention.
• Distribute testing samples to In-house Analytical, Elemental and Microbiology Labs.
• Prepare In process Labels for production, and QA samples to be provided along with the Batch Records.
• Work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
• Comply with all job-related safety and other training requirements.
• Keep management informed of area activities and of any significant problems.

Benefits

• Medical, dental, vision insurance.
• Short and long term disability.
• Basic life insurance.
• Supplemental life insurance.
• AD&D insurance.
• Matched 401(k) savings plan.
• Compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc.
• Up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree