Jobs in the United States

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Added 3 mins ago
Assistant Store Manager (40) Gateway
TD Bank, N.A.
Columbia, SC
The Assistant Store Manager is an experienced leader who manages the day-to-day service, sales, and operational objectives in a Store location. The role is focused on leading a team to grow…
Added 13 mins ago
A
Program Lead II
AbbVie
North Chicago, IL
- $160,500 to $305,000 USD / year
Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts and ensures effective change management across the cross-functional…
Added 32 mins ago
SO
Director of Internal Audit - State Program Administrator Manager Principal
State of Minnesota
MN
- $50.04 to $71.75 USD / hour
Job Class: State Program Administrator Manager, Principal
Added 33 mins ago
Manager Fiscal Services Actuals & Audits
Oakland County
Waterford, MI
Direct the development, maintenance, and improvement of accounting systems and financial technology.
Added 43 mins ago
J
Sr. Program Manager - Core Team Leader
Jobgether
Remote, United States
- $199,681 to $221,675 USD / year
…applications and next steps. Our partner is looking for a Sr. Program Manager - Core Team Leader based in the United…
Added 45 mins ago
Clinical Staff Leader - Pediatric Hematology
Vanderbilt University Medical Center
Nashville, TN
…evaluation of assignment work processes, constantly striving for improvement in the way tasks and activities are accomplished by questioning their value to the process and contributing…
Added 45 mins ago
Clinical Oncology Pharmacy Manager
Vanderbilt University Medical Center
Nashville, TN
Pharmacy Program Management (Advanced): Demonstrates the uppermost levels of expertise in challenging and complex situations. Often takes a lead role in highly pressurized situations when…
Added 55 mins ago
Controller - AF050
Department of General Services (DGS)
Richmond, VA
State Role Title: Financial Services Manager II
Added 57 mins ago
W
Human Resource Office/Training Manager (Fashion, Grocery, Import, Regional, Returns, Sam's, Wm.Com)
Walmart
WESTAMPTON, NJ
- $72,050 to $108,000 USD / year
…measuring progress in achieving results identifying and addressing improvement opportunities and demonstrating adaptability and promoting continuous learning Provides supervision and…
Added 57 mins ago
EA
College Intern - HR Information Systems Analyst
Envoy Air Inc.
Irving, TX
- $22 USD / hour
Gain hands-on experience in HRIS, project management, change management, process improvement, and employee technology while supporting cross-functional initiatives
Added 57 mins ago
EA
College Intern - Supply Chain
Envoy Air Inc.
Irving, TX
- $22 USD / hour
Enrolled in an undergraduate or graduate degree program in: supply chain, business administration, data analytics, industrial engineering, human resources, computer science, or related field
Added 59 mins ago
Assistant Store Manager
Staples Canada
Norridge, IL
Full-time hours, generous paid time off, career development program and weekly pay
Added 1 hour ago
Program Manager Project Delivery OE
DHL
Westerville, OH
The Program Manager Project Delivery OE (US-O) role has a national salary range of $104,000- $198,000.
Added 1 hour ago
J
Project Controls Manager (Wind Renewables Construction)
Jobgether
Remote, United States
- $120,000 to $160,000 USD / year
The Project Controls Manager will oversee and strengthen project controls practices across multiple large-scale renewable energy construction projects. This role combines strategic…
Added 1 hour ago
YA
QUALITY INSPECTOR I - RES
YKK AP America Inc.
macon, GA
- $18.27 to $20.75 USD / hour
Communicates significant issues or developments identified to Quality Manager during quality assurance activities and provides recommended process improvements for review.
Added 1 hour ago
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Area Manager
Aerotek
San Diego, CA
- $30 to $40 USD / hour
Engage in quality and process improvement techniques, identifying problem areas and initiating corrective actions.
Added 1 hour ago
Strategic Marketing Manager - Endosafe (REMOTE)
Charles River
Remote, United States
The Strategic Marketing Manager supports marketing across the Microbial Solutions portfolio, with a dedicated focus on the Endosafe® endotoxin testing business. This role bridges strategic…
Added 2 hours ago
Strategic Marketing Manager - Endosafe (REMOTE)
Charles River Laboratories
Wilmington, MA
The Strategic Marketing Manager supports marketing across the Microbial Solutions portfolio, with a dedicated focus on the Endosafe® endotoxin testing business. This role bridges strategic…
Added 2 hours ago
Program Manager
ThermoFisher Scientific
Boston, MA
The Program Manager, Customer Site Manager serves as the primary point of contact for Unity™ Lab Services at a customer account with multiple U.S. locations. This role oversees on-site…
Added 2 hours ago
Senior Manager, Commissioning Engineering
Devens
Devens, MA
The position, Sr. Manager Commissioning Engineering will be part of the Validation team reporting to the Associate Director, Validation Engineering and support clinical and commercial…
Added 2 hours ago
Senior Manager, Embedded Software - Engines
Blue Origin Personnel, LLC
Huntsville, AL
…collaboration with Enterprise functions is essential to meet program…
Added 2 hours ago
Partner Manager – MedSpa
Jobgether
Remote, United States
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Partner Manager – MedSpa based in United States .
Added 2 hours ago
Improvement Engineer
Olin Corporation
US-TX-Freeport
The Improvement Engineer leads the plant-level improvement process by gathering and analyzing data, evaluating improvement opportunities, and implementing improvement projects. This role…
Added 2 hours ago
A
Environmental Manager
Actalent
Deer Island, OR
- $82 to $88.95 USD / hour
Job Title: Environmental ManagerJob DescriptionThe Environmental Manager leads environmental compliance programs and oversees laboratory operations within a complex industrial manufacturing…
Added 2 hours ago
A
Project Manager
Actalent
Simi Valley, CA
- $48.08 to $67.31 USD / hour
Job Title: Project ManagerJob DescriptionWe are looking for an experienced Project Manager to join our team at a leading aerospace and defense manufacturer in Simi Valley. The successful…

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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