Biofarma Group · 1 day ago
Senior Coordinator, Quality Assurance
North Brunswick, NJ, US
Full-time
Onsite
Mid, Senior Level
$60K/yr - $75K/yr
3+ years expBiofarma Group is seeking a Senior QA Coordinator to support their Quality Assurance department in ensuring compliance with quality standards in the nutraceutical manufacturing environment. This role involves coordinating quality assurance programs, overseeing documentation systems, and collaborating with various internal teams to maintain product quality and regulatory compliance.
CosmeticsHealth CareManufacturingPharmaceutical
Responsibilities
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
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
Qualification
Required
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
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
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 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
Preferred
Experience with electronic Quality Management Systems (eQMS)
Benefits
Medical
Dental
Vision
Short and long term disability
Basic life insurance
Supplemental life insurance
AD&D insurance
Matched 401(k) savings plan
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
Company
Biofarma Group
Biofarma Group is a company active in the development, manufacturing and packaging of food supplements, medical devices and cosmetics.
Founded in 1987Mereto Di Tomba, Friuli-Venezia Giulia, ITA
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2022-01-17Acquired
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