Jobs in the United States

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Added 32 mins ago
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Japanese Handroll Restaurant Associate
Marukai Corporation
West Covina, CA
- $18 to $20 USD / hour
Added 1 hour ago
R
Pick and Pack Associate
Ritalka
Watertown, SD
- $18 to $20 USD / hour
…------------------------------------------------------------------------ The Pick and Pack Associate is responsible for accurately picking parts and materials from designated shelf…
Added 1 hour ago
R
Shipping and Receiving Associate
Ritalka
Watertown, SD
- $18 to $20 USD / hour
…------------------------------------------------------------------------ The Shipping and Receiving Associate will ensure accurate packaging of outbound orders, coordinate shipments and…
Added 1 hour ago
BP
Environmental Monitoring Program Coordinator
Barrett Petfood
Little Falls, MN
- $24.5 to $28 USD / hour
…execution and continuous innovation takes pet food manufacturing, packaging and distribution to differentiating levels. With a relationship focus and a family feel, we offer many career…
Added 1 hour ago
BP
Regulatory Coordinator
Barrett Petfood
Brainerd, MN
- $24.5 to $28 USD / hour
…execution and continuous innovation takes pet food manufacturing, packaging and distribution to differentiating levels. With a relationship focus and a family feel, we offer many career…
Added 4 hours ago
Assembly Operator - Shift 1
Summit Polymers
Kalamazoo, MI
Under the direct supervision of the department supervisor, the Production Operator/Associate is assigned to standardized work of routine nature involving molding machine operation and/or…
Added 4 hours ago
A
Production Associate
Aerotek
Omaha, NE
- $18.34 to $19.34 USD / hour
$18-20/hr!Job DescriptionThe Production Associate is responsible for operating equipment, assembling products, and ensuring that all quality standards are met. This role is crucial in…
Added 5 hours ago
Bulk Pack Associate
RS Group
Fort Worth, TX
Examines packaging and contents of items for conformance to company specifications.
Added 5 hours ago
SC
QA Specialist I
Sofie Co.
Totowa, NJ (NJ3), NJ
- $33 to $36 USD / hour
▪ Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these…
Added 5 hours ago
Warehouse Associate II
Arrow Electronics
Phoenix, AZ
Pull, prep, and complete shipping orders via RF scanners, paperwork, and box packaging
Added 6 hours ago
Assembly Line Associate-1st shift
Express Employment Professionals
Sevierville, TN
Added 6 hours ago
PM Deli Lead-East Norriton, PA
Albertsons Companies
EAST NORRITON, PA · East Norriton, PA
Oversee preparation, slicing, cooking, packaging, and merchandising of deli items following company recipes and standards
Added 6 hours ago
TI
Machine Shop Support Technician (Grinding & Swiss)
Tolomatic, Inc.
Medina, MN
- $38 to $50 USD / hour
Associate's degree or two years of technical training in machine tool technology or a related field.
Added 7 hours ago
Associate Environmental Compliance and Sustainability Engineer - NH, MA
Extreme Networks, Inc.
United States
As an Associate Environmental Compliance & Sustainability Engineer, you will join a small, global team and learn from experienced engineers while contributing to real work from day one. The…
Added 7 hours ago
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Press Support Feeder Operator 2nd Shift
Spherion
Raleigh, NC
- $19 to $22 USD / hour
We are hiring a press operator support associate. In this role, you will assist the lead Press Operators by operating the feeder and consistently keeping the press running, keeping the inks…
Added 8 hours ago
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Food Production Associate
ManpowerGroup
Willard, OH
- $16 to $17 USD / hour
The Food Production Associate is an entry-level role responsible for supporting daily manufacturing operations. Team members rotate through multiple production positions to ensure efficient…
Added 8 hours ago
Material Handler - Forklift (1st Shift)
AMERICAN AXLE & MANUFACTURING INC
Bowling Green, OH
…paper). - Complete service orders, service boxes, and coordinate packaging material requirements. - Prepare, band, and package finished goods and components for shipment. - Maintain a clean…
Added 8 hours ago
Warehouse Associate
Ohiomeansjobs Lake County
Mentor, OH
OhioMeansJobs | Lake County is accepting resumes for the following position: Position: Warehouse Associate Location: Mentor, OH Hours: Full Time Pay: Based On Experience Position ID: 3295…
Added 8 hours ago
Endpoint Infrastructure and AVD Engineer - Associate
RSM US LLP
Cincinnati, OH
Added 8 hours ago
Meat - Seafood Clerk
Albertsons Companies
LUBBOCK, TX · Lubbock, TX
…join our team! In this role, you’ll assist with preparing, packaging, and displaying fresh meat and seafood products while ensuring top-notch quality and food safety standards. You’ll help…
Added 9 hours ago
Brand Manager
Wente Family Estates
Livermore, CA
Oversee the Outshinery process for bottle photography, including new vintages, packaging updates, and asset distribution.
Added 9 hours ago
BP
Production Warehouse Associate
Belt Power LLC
West Chester, OH
- $21 to $25 USD / hour
…Power LLC is looking for a dependable Production Warehouse Associate to support warehouse operations, shipping and receiving, conveyor belt fabrication, and customer-site…
Added 10 hours ago
Fresh Cut Produce Clerk
Albertsons Companies
BLACK DIAMOND, WA · Black Diamond, WA
As a Fresh Cut Produce Clerk, you’ll be hands-on with fresh fruits and vegetables - slicing, dicing, and packaging produce to perfection. You’ll check for freshness, maintain clean and…
Added 10 hours ago
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Production Associate
Staffmark
Lebanon, TN
- $18 USD / hour
As a Production Associate you will support daily manufacturing operations by assembling products, operating production equipment, inspecting finished goods, packaging materials, maintaining…
Added 11 hours ago
Fresh Cut Produce Clerk
Albertsons Companies
GERMANTOWN, MD · Germantown, MD
As a Fresh Cut Produce Clerk, you’ll be hands-on with fresh fruits and vegetables - slicing, dicing, and packaging produce to perfection. You’ll check for freshness, maintain clean and…

Sofie Co.

QA Specialist I

Totowa, NJ (NJ3), NJ, United States

$33 to $36 USD / hour

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Job details

Pay: $33 to $36 USD / hour
Experience: ▪ 1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience
Posting language: English
Posted: Oct 30, 2026

Original job description

Overview

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level. Essential Duties and Responsibilities

Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
Ensure that personnel are properly trained and qualified. Ensure that the training is documented.
Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).
Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.
Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.
Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., owning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
Ensure any deviations from normal procedures are documented and justified.
Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).
Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.
Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.
Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.
Expected extensive knowledge of up to two SOFIE products
Other responsibilities as required.

Qualifications

Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.
Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
Quality, Pharmacy, or CGMP manufacturing experience preferred.
Knowledge of USP, FDA, and cGMP regulations preferred.
Knowledge of how and ability to write, review, and revise SOPs required.
Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
Ability to write reports, business correspondence, and procedure manuals required.
Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.
Ability to define problems, collect data, establish facts, and draw valid conclusions required.
Ability to solve problems and handle issues required.
Proficient in MS Office applications required.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required. Requirements for Quality Assurance Specialist (QAS) I
Associate’s or Bachelor’s Degree, at minimum
Relevant certifications and/or experience may be substituted in lieu of this requirement
1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience

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More about this job

Skills

Quality assurance
Quality assurance procedures
SOFIE
Quality assurance methodologies
Regulatory compliance
Collaboration
Problem solving
Process improvement
Communication skills
Packaging
Cleaning
Sanitation
Write work-related reports
Provide training
Gather data
Microsoft Office

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