Biofarma Group · 1 month ago
Associate, In-Process QA Probiotics
North Brunswick, NJ, US
Full-time
Onsite
New Grad, Entry, Mid, Senior Level
$24/hr - $30/hr
0+ years expBiofarma Group is a company focused on quality assurance in the nutraceutical industry. The Associate, In-Process QA Probiotics will perform line inspections and in-process quality testing during manufacturing and packaging, ensuring compliance with GMP and SOP standards.
CosmeticsHealth CareManufacturingPharmaceutical
Responsibilities
Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes
Perform In-process checks: Blend uniformity sampling, Tablet/capsule weight variation, Hardness, friability, and disintegration tests etc as applicable
Verify equipment cleaning and area hygiene as per SOP
Collect and label In-process and stability samples under supervision
Ensure line clearance before packaging activities
Perform In-process checks: Batch number and expiry date printing, Label application and carton sealing, Primary and secondary packaging integrity etc as applicable
Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels)
Record observations in IPQA checklists, logbooks, and batch records
Maintain GMP documentation in real-time (legible and error-free)
Escalate any deviation or abnormality immediately to the QA Executive/Supervisor
Adhere to company GMP, SOP, and Hygiene policies
Use PPE appropriately
Support during internal/external audits by providing necessary records
Cleans up work following the completion of a shift
Meets all safety expectations and follows all safety practices
Works extended hours and occasional weekend overtime
Other duties as assigned
Supervise and verify line clearance activities across all manufacturing and packaging areas
Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs)
Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable, Environmental monitoring records, Equipment and area cleaning records
Coordinate and monitor sampling activities for In-process, finished products and stability studies
Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
Cross-check reconciliation of raw materials and printed packaging materials
Verify proper use of status labels (approved/rejected/quarantine)
Investigate and document process deviations, non-conformances, and OOS/OOT incidents
Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA)
Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events
Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.)
Conduct routine GMP audits, spot checks, and area inspections
Guide and mentor IPQA Level 1 and Level 2 personnel
Allocate daily QA responsibilities and monitor adherence to QA procedures
Conduct on-the-job training for new team members
Qualification
Required
0–1 year experience for IPQA – Level 1
Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company for IPQA – Level 2
3–5 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing for IPQA – Level 3
High School diploma is required
Basic understanding of GMP, nutraceutical processes, and QA principles for IPQA – Level 1
Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals for IPQA – Level 2
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance for IPQA – Level 3
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
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
Preferred
Freshers with training or internship in QA preferred
BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus
Benefits
Medical
Dental
Vision
Short and long term disability
Basic life insurance
Supplemental life insurance
AD&D insurance
Matched 401(k) savings plan
Overtime
Shift differential
Holiday pay
Sick time
Up to 10 days of vacation the first year
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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