Role Overview |
The Senior QA Coordinator plays a key role in supporting the Quality Assurance department by ensuring compliance to SOPs, batch records, master manufacturing records, GMP documentation and to 21 CFR Part 111 and 117 and other relevant quality standards in the nutraceutical manufacturing environment. This position will be responsible for coordinating quality assurance programs designed to ensure continuous production of products and includes tracking products, materials, status, and location. Involved in the issuance /review of batch records, on floor collection of samples , preparation of Master compliance documents and participating in audit preparations . |
Areas of Responsibility |
- Oversee and maintain GMP documentation systems, including SOPs, batch records, deviations, CAPAs, change controls, and training records.
- Issuance of Manufacturing / Coating / Packaging Batch Cards
- Collects samples from on floor production for further testing and retention
- Distributes testing samples to Inhouse testing Analytical , Elemental and Microbiology Lab
- Preparation of different types of In process Labels for production , QA samples to be provided along with the Batch Records
- Scanning , photocopy, filing of GMP documents per Batch Product requirements
- Coordinate Finished Product release in Syspro
- Performs Sampling of materials / products per procedures as needed
- Reads and understands approved specifications/standards assigned to the project
- Keeps up to date with the regulatory requirements around documentation and implements changes if necessary.
- Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements.
- Collaborate with Manufacturing, R&D, QC, and Regulatory teams to ensure seamless execution of quality processes.
- Play an active role on quality management team within the organization
- Any other duties which may be assigned from time to time
Other Responsibilities Including Safety: - Works in a safe and responsible manner to create an injury-free and incident-free workplace.
- Complies with all job-related safety and other training requirements.
- Keeps management informed of area activities and of any significant problems.
|
Requirements |
Education & Qualification: - Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field.
- Minimum 3–5 years of QA experience in a nutraceutical, dietary supplement, or pharmaceutical manufacturing environment.
- Strong knowledge of GMP, 21 CFR Part 111,117 and other relevant quality standards.
- Detail-oriented with strong organizational and documentation skills.
- Proficient in Microsoft Office; experience with electronic Quality Management Systems (eQMS) preferred.
- Excellent communication and problem-solving skills.
Certifications, Licenses, Credentials: Skills & Ability - In-depth understanding of nutraceutical manufacturing processes and regulatory compliance.
- Proficient in QA documentation, process audits, and deviation handling.
- Strong analytical and decision-making skills.
- Familiar with QMS tools, GMP documentation, and data integrity principles.
- Working knowledge of SOP writing, change control, and risk assessment.
Physical Requirements (lifting, etc.): - Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
- Must stand and walk on production floor a minimum of 6 hours per shift
- 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 to 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 and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees 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 :- General Shift 8.30am – 5.00 pm or extended
