Jobs in the United States

25+ jobs

Save this search

Added just now
Events Management INTERN
Focus on the Family
Colorado Springs, CO
The Focus on the Family Internship Program provides valuable experience, professional and spiritual development, and lasting friendships for over 30 college upperclassmen each summer.…
Added 5 mins ago
Lead Cashier
Ulta Beauty, Inc.
North Little Rock, AR
Share the benefits of the guest loyalty program, including credit and the Ulta Beauty app, with guests, lead associates to do the same, and create excitement and accountability to…
Added 5 mins ago
Merchandise Manager
Ulta Beauty, Inc.
Beaumont, TX
The Merchandise Manager (MM) is responsible for leading through Ulta Beauty’s mission, vision, and values and contributing to a high-performing team that consistently delivers top-line…
Added 5 mins ago
UB
Operations Manager
Ulta Beauty, Inc.
Federal Way, WA
- $28 to $35 USD / hour
The Operations Manager (OM) is responsible for leading through Ulta Beauty’s mission, vision, and values in order to develop a high-performing team that consistently delivers top-line sales…
Added 5 mins ago
UB
Merchandise Manager
Ulta Beauty, Inc.
Eureka, CA
- $20 to $29 USD / hour
The Merchandise Manager (MM) is responsible for leading through Ulta Beauty’s mission, vision, and values and contributing to a high-performing team that consistently delivers top-line…
Added 5 mins ago
UB
Lead Cashier
Ulta Beauty, Inc.
Chino, CA
- $17.5 to $26 USD / hour
Share the benefits of the guest loyalty program, including credit and the Ulta Beauty app, with guests, lead associates to do the same, and create excitement and accountability to…
Added 5 mins ago
Program Manager Principal, PS Operations Automation Team
FIS INC (OLD FIS)
United States
Negotiate, plan, and execute change management of new solutions to ensure that the right employee and client outcomes are achieved with the deployment of new technology solutions.
Added 5 mins ago
Program Manager Principal, PS Operations Automation Team
FIS INC (OLD FIS)
United States
Negotiate, plan, and execute change management of new solutions to ensure that the right employee and client outcomes are achieved with the deployment of new technology solutions.
Added 6 mins ago
CO
Systems Analyst I/II
City of Escondido
Escondido, CA
- $44.03 to $66.76 USD / hour
…level are not expected to function with the same amount of program knowledge or skill level as positions allocated to the Systems Analyst II level and exercise less independent discretion…
Added 6 mins ago
CO
Business Analyst I/II
City of Escondido
Escondido, CA
- $37.04 to $60.48 USD / hour
…level are not expected to function with the same amount of program knowledge or skill level as positions allocated to the Business Analyst II level and exercise less independent discretion…
Added 6 mins ago
Assistant Manager II
Family Dollar Stores Of Wisconsin LLC
Mauston, WI
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 6 mins ago
Assistant Manager II
Family Dollar Stores Of South Carolina LLC
Spartanburg, SC
We’re seeking an Assistant Store Manager to join our team to help with store operations, customer service and team development. Duties include, but are not limited to, the following:
Added 14 mins ago
Release Train Engineer
Regions Bank
Charlotte, NC · Birmingham, AL · Atlanta, GA
Collaborates with the Program Management Office (PMO) to maintain solid program execution and operational excellence
Added 16 mins ago
Habitat GIS and Data Specialist
Pacific States Marine Fisheries Commission
Portland, OR
The Ecosystem GIS and Data Specialist supports the Pacific States Marine Fisheries Commission (PSMFC) Habitat Program by assisting with data stewardship, geospatial analysis, scientific…
Added 16 mins ago
PH
Shift Leader 2.0
Progressive HR Strategies Inc
New Orleans, LA
- $16 to $18 USD / hour
The Front of House Shift Leader is a hands-on hourly leader who supports the Front of House Manager with the daily management and execution of The Warbler Hotel's food and beverage…
Added 16 mins ago
PH
FOH Manager 4.0 Food & Beverage Team
Progressive HR Strategies Inc
New Orleans, LA
- $45,000 to $60,000 USD / year
The Food and Beverage program, at the Warbler Hotel will be developed in partnership with CureCo., the New Orleans hospitality group led by Neal Bodenheimer and Kirk Estopinal, whose…
Added 17 mins ago
HUMAN RESOURCES SPECIALIST (MILITARY) (Title 32)
Army National Guard Units
Rapid City, SD
Added 27 mins ago
Operations Manager - Hauling
BFI WASTE SERVICES OF TEXAS, LP
Beaumont, TX
POSITION SUMMARY: Within a business unit, the Operations Manager - Hauling is responsible for managing the collections activities for commercial, industrial and residential customers, as…
Added 30 mins ago
Plant HR Manager
Toppan Flexible Packaging Inc
Elk Grove, IL
While reporting to TOPPAN’s Sr. Plant HR Manager, the Plant HR Manager is responsible for handling employee relations activities at designated plant location(s) as assigned.…
Added 30 mins ago
Priority Health Medicare Quality Pharmacy Intern
Corewell Health Corporate
Grand Rapids, MI
…managed care pharmacy, population health, medication therapy management, Medicare Stars quality measures, and member and provider engagement. The intern will have opportunities to apply…
Added 40 mins ago
Senior Manager Enterprise Service Management & ServiceNow
SRP
Tempe, AZ
The Senior Manager, Enterprise Service Management & ServiceNow is the enterprise product and technology leader accountable for the vision, multi-year strategy, investment portfolio,…
Added 48 mins ago
Real-Time Information Center (RTIC) Manager
UWMSN University of Wisconsin Madison
Madison, WI
The ideal candidate will possess exceptional project management, communication, strategic planning, and relationship-building skills, with the ability to coordinate complex initiatives…
Added 48 mins ago
M
Warehouse Lead - PTS, Columbus - Full Time
Macy's
Columbus, OH
- Full-time
The Warehouse Lead is responsible for achieving daily department goals set by the Operations Manager. They will monitor hour by hour performance, adjust staffing as needed, and provide…
Added 49 mins ago
M
Asset Protection Captain, White Marsh - Full Time
Macy's
Nottingham, MD
- Full-time
Support special assignments, investigations, surveillance, and alarm response as directed by the Store Asset Protection Manager.
Added 49 mins ago
M
Retail Fragrances Sales Specialist - Armani/Valentino, Westland - Full Time
Macy's
Hialeah, FL
- Full-time
Employee Assistance Program with mental health counseling and legal/financial advice

Sofie Co.

QA Specialist I

Totowa, NJ (NJ3), NJ, United States

$33 to $36 USD / hour

Apply About employer

Applications open in a new tab.

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

Apply About employer

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

Report this job