Jobs in the United States

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Added 2 mins ago
Pharmacy Technician
CVS Pharmacy, Inc.
Cameron, TX
Once in role, Technicians are required to complete a rigorous company training program and satisfy all registration, licensing, and certification requirements according to their State’s…
Added 2 mins ago
M
Starbucks Barista, Chandler Fashion Center - Part Time
Macy's
Chandler, AZ
- Part-time
…shifts as part of the requirements. Hours are dependent on business needs and colleague availability. Information regarding hours per week needed for benefit eligibility purposes can be…
Added 13 mins ago
Medical Management Specialist I
The Elevance Health Companies, Inc.
United States
The Medical Management Specialist I is responsible for providing non-clinical support to the Medical Management and/or Operations areas.
Added 21 mins ago
Manager Fiscal Services Actuals & Audits
Oakland County
Waterford, MI
…professional to provide leadership and oversight of County financial operations, accounting practices, and fiscal policies. In this role, you'll play a key part in ensuring financial…
Added 21 mins ago
Chief Fiscal Services
Oakland County
Waterford, MI
Prepares or supervises the preparation of special financial reports to the division manager, department director, County Executive and elected officials or other parties requesting…
Added 31 mins ago
CH
Pharmacy Technician
CVS Health
Rancho Mirage, CA
- $18.55 USD / hour
Once in role, Technicians are required to complete a rigorous company training program and satisfy all registration, licensing, and certification requirements according to their State’s…
Added 31 mins ago
CH
Pharmacy Technician
CVS Health
Rancho Mirage, CA
- $18.55 USD / hour
Once in role, Technicians are required to complete a rigorous company training program and satisfy all registration, licensing, and certification requirements according to their State’s…
Added 33 mins ago
Clinical Staff Leader - Pediatric Hematology
Vanderbilt University Medical Center
Nashville, TN
…This leadership role, often categorized as an Assistant Nurse Manager, involves overseeing clinical excellence and managing a multidisciplinary healthcare…
Added 43 mins ago
Special Events Specialist
City of Georgetown
United States
Under the supervision of the Special Events & Marketing Program Manager. The Special Events Specialist assists with the planning, coordination, implementation, and evaluation of…
Added 43 mins ago
Controller - AF050
Department of General Services (DGS)
Richmond, VA
State Role Title: Financial Services Manager II
Added 44 mins ago
W
(USA) Area Manager - Floor (Wm.Com)
Walmart
CHINO, CA
- $78,600 to $118,000 USD / year
…shopping experience for customers around the country? The Area Manager is a critical operational role within our distribution & fulfillment centers that thinks strategically and leads…
Added 45 mins ago
W
(USA) Area Manager - Floor (wm.com)
Walmart
SPARKS, NV
- $65,500 to $98,000 USD / year
…shopping experience for customers around the country? The Area Manager is a critical operational role within our distribution & fulfillment centers that thinks strategically and leads…
Added 48 mins ago
Assistant Store Manager
Staples Canada
Norridge, IL
Assistant Managers drive sales, services and customer engagement in the store and ensure the store is ready for business. You and your team will establish customer relationships that build…
Added 1 hour ago
PF
Club Manager
Planet Fitness - PF Baseline Fitness
Santa Paula, CA
- $23.1 USD / hour
Responsible for oversight of gym operations to ensure positive member experience and a financially successful club.
Added 1 hour ago
PF
Club Manager
Planet Fitness - PF Baseline Fitness
Camarillo, CA
- $24.05 USD / hour
Responsible for oversight of gym operations to ensure positive member experience and a financially successful club.
Added 1 hour ago
Region Director - Sickle Cell Sales - West
Novo Nordisk
Los Angeles, CA
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
Region Director, Sickle Cell Sales - New England
Novo Nordisk
New York, NY
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
Region Director, Sickle Cell Sales - Central
Novo Nordisk
Chicago, IL
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
Region Director - Sickle Cell Sales- Mid-Atlantic
Novo Nordisk
Philadelphia, PA
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
OCONUS Logistics Manager
GD Information Technology, Inc.
United States
GDIT is seeking an experienced OCONUS Logistics Manager to support the IBD-SS program and Product Manager Force Protection Systems (PM FPS). This role serves as the senior logistics lead…
Added 1 hour ago
Store Manager
Bridgestone Retail Operations, LLC.
United States
Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including…
Added 1 hour ago
Sales and Service Technician
Bridgestone Retail Operations, LLC.
United States
Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including…
Added 1 hour ago
Region Director, Sickle Cell Sales - New England
New York
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
Region Director, Sickle Cell Sales - Central
Chicago
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…
Added 1 hour ago
Region Director - Sickle Cell Sales- Mid-Atlantic
Philadelphia
…representatives and is responsible for managing a Regional Business Unit. This supervisory role will internally work closely with all members across Rare Disease/Sickle Cell Field…

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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