Associate, QA Operation Support
5 days ago
North Brunswick
Job Description Job Description Date 7/2025 Location 1300 Airport Road, North Brunswick NJ Title Associate, QA Operation Support Department Quality Assurance Reports to Manager, QA Operations FLSA (Exempt or Non-Exempt Exempt Role Overview 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. Areas of Responsibility Level 1 - Associate, QA Operations Support Summary of the Role: Entry-level position in the QA department focused on supporting sampling and/or dispensing activities under supervision. Intended for fresh graduates or new entrants to the pharmaceutical QA function. ???? Key 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. Level 2 – Associate, QA Operations Support ???? Summary of the Role: Responsible for performing QA-related sampling and/or releasing , dispensing activities in compliance with SOPs and regulatory requirements. Ensures proper documentation and real-time quality assurance during material handling. ???? Key Responsibilities: • 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. Level 3 – Associate, QA Operations Support ???? Summary of the Role: Mid-level QA role with responsibility for overseeing sampling and dispensing operations. Ensures compliance, accuracy, and efficiency of all QA activities in the function. ???? Key Responsibilities: • 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., • Performs issuance of batch cards of Manufacturing, Coating and Packaging., • Collects samples from on floor production for further testing and retention., • Distributes testing samples to In-house Analytical , Elemental and Microbiology Labs, • Prepares In process Labels for production ,and QA samples to be provided along with the Batch Records Other Responsibilities Including Safety: • Works in a safe and responsible manner in order to create an injury-free and incident-free workplace., • Complies with all job-related safety and other training requirements. Education & Qualification: Level 1 – Associate, QA Operations Support • B.Sc. / B.Pharm. or equivalent in a science-related field., • Relevant QA experience working within a GMP and/or with GCP regulations. Level 2 – Associate, QA Operations Support • B.Sc. / B.Pharm. (required), • 1–3 years of experience in QA or related area preferred working within a GMP and/or with GCP regulations. Level 3 – Associate, QA Operations Support • B.Sc. / B.Pharm. (minimum); M.Sc. / M.Pharm. preferred, • 3–6 years of relevant QA experience working within a GMP and/or with GCP regulations. Certifications, Licenses, Credentials: • N/A Skills & Ability Level 1 – Associate, QA Operations Support • Willingness to learn and follow instructions., • Basic understanding of GMP (preferred)., • Good observational and documentation skills., • Teamwork and adaptability. Level 2 – Associate, QA Operations Support • Working knowledge of cGMP and SOPs., • Attention to detail and strong documentation habits., • Familiarity with quality systems (e.g., logbooks, traceability)., • Communication and coordination abilities Level 3 – Associate, QA Operations Support • Strong knowledge of cGMP and quality systems., • Leadership and team management skills., • Effective communication and problem-solving., • Ability to handle audits, deviations, and cross-functional coordination., • Good documentation and review capabilities. Physical Requirements (lifting, etc.): • Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds., • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances., • Occasionally works from a rolling ladder or step stool., • Must be able wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.): • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. shift schedule 1st shift: 7:00 AM - 3:30 PM, 2nd shift: 3:00 PM - 11:30 PM and 3rd shift: 11:00 PM - 7:30 AM 2nd shift - 3:00 PM to 11:15 PM
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