Jobs in the United States

25+ jobs

Save this search

Added just now
MC
Japanese Handroll Restaurant Associate
Marukai Corporation
West Covina, CA
- $18 to $20 USD / hour
Added 7 mins ago
Coordinator for Academic Programs
Harvard University
Cambridge, MA
Reporting to the Associate Dean for Academic Programs, the Coordinator for Academic Programs provides high-level administrative, programmatic, and project coordination support for the…
Added 7 mins ago
Financial Associate
Harvard University
Cambridge, MA
Reporting to the Financial Manager, the position is part of a team supporting Harvard College Admissions and Financial Aid Office’s financial operations.
Added 10 mins ago
Registered Nurse (RN) - Tier II Market Float - Hampton Roads
Bon Secours Mercy Health Inc
Norfolk, VA · Portsmouth, VA · Newport News, VA · Suffolk, VA · Franklin, VA
…team in cooperation with and under the direction of a clinical manager or designee as defined by the relevant Standards and Scope of Practice for the Registered…
Added 13 mins ago
SE
Optical Associate, Non-Certified – Sam’s Club - PT
Sam's East, Inc.
Katy, TX
- $19.5 to $27.5 USD / hour
…repairs. As needed and under guidance of the contracted or associate optometrist, completes patient appointments performs pre-testing, and records results. Embraces the utilization of new…
Added 13 mins ago
Representative, New Business Support - Life
Nationwide Life and Annuity Insurance Co
OH
We are seeking a motivated and detail-oriented New Business Support Associate to join our Life New Business team. In this role, you will provide essential support to ensure the smooth…
Added 21 mins ago
Account Manager / Specialty Account Manager - IgG4 (Rare Disease) - Wilmington, DE
Amgen
Wilmington, DE
Account Manager/Specialty Account Manager, IgG4-RD
Added 47 mins ago
Showroom Manager
Ferguson Enterprises, LLC
Evansville, IN
Ferguson is currently seeking the right individual to fill an immediate need for a Showroom Manager in our Evansville, IN Bath, Kitchen & Lighting Showroom.
Added 51 mins ago
A
Parts Coordinator - $15/hr
AutoNation
Waco, TX
- $15 USD / hour
Determine availability and provide necessary information for out-of-stock parts and secure approval for special and/or emergency orders by Collision Manager
Added 55 mins ago
Child Care Assistant - 26/27 School Year
Etiwanda School District
Etiwanda, CA
Under the direction and supervision of the Child Care Manager, to perform a variety of instructional activities; to assist in creating and organizing a safe and healthy child care program…
Added 56 mins ago
Lead Cashier
Ulta Beauty, Inc.
North Little Rock, AR
…guest experience, and loyalty), people (guest service, and associate training and development), and process (operating procedures and compliance standards with an emphasis on cashiering).…
Added 56 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 56 mins ago
Specialty Beauty Advisor - Clinique
Ulta Beauty, Inc.
Conroe, TX
…Clinique brand to the Ulta Beauty guest and support the Experience Manager (EM) through a focus on performance (service/retail sales and in-store events), people (guest service and…
Added 56 mins ago
UB
Operations Manager
Ulta Beauty, Inc.
Federal Way, WA
- $28 to $35 USD / hour
Support all aspects of manager and associate professional development, including training, providing individualized competency-based feedback and coaching, performance reviews, succession…
Added 56 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 56 mins ago
Assistant Stylist
Ulta Beauty, Inc.
Covington, WA
Communicate any supply needs to the Experience Manager, ensuring guest-readiness at all times.
Added 56 mins ago
UB
Lead Cashier
Ulta Beauty, Inc.
Chino, CA
- $17.5 to $26 USD / hour
…guest experience, and loyalty), people (guest service, and associate training and development), and process (operating procedures and compliance standards with an emphasis on cashiering).…
Added 1 hour ago
UH
Access Care Representative
UHS Hospitals
Binghamton, NY
- $17.05 to $22.17 USD / hour
This is a per diem position, which means you will work on an as needed, agreed upon basis. Working hours will be assigned by your manager.
Added 1 hour ago
Release Train Engineer
Regions Bank
Charlotte, NC · Birmingham, AL · Atlanta, GA
Bachelor's degree in Computer Science or a related field and ten (10) years of experience as a Release Train Engineer, Scrum Master, Product Owner, or Agile Project/Program Manager
Added 1 hour ago
Relationship Banker I - Harpeth Village Branch
Regions Bank
Nashville, TN
…including completing duties delegated and assigned by the Branch Manager; as a member of the branch team, ensures sound banking practices, including managing, identifying and reporting…
Added 1 hour ago
SR Manager Operations
LOGISTICS INSIGHT CORP.
LINC-RACINE, WI
The Operations Manager is responsible for overseeing the day-to-day warehouse operation, ensuring safety, productivity, quality, and customer expectations are consistently achieved. This…
Added 1 hour ago
Electro-Mechanical Assistant Site Manager
Dematic Corp. (ILD-US)
Union City, GA
Dematic Corp. is seeking an Assistant Site Manager for our Resident Maintenance team. The Resident Maintenance Assistant Site Manager is responsible for leading maintenance teams and…
Added 1 hour ago
M
Retail Fragrances Sales Support Associate - Dior, Oakridge - Part Time
Macy's
San Jose, CA
- Part-time
Partner with Fragrance Counter Manager or CSX Manager of inventory and other inaccuracies
Added 1 hour ago
Regional Real Estate Manager
Wawa Inc. (210515330)
Remote, United States
Job Summary: Regional Real Estate Manager manages assets which include site review, acquisition and development of new store locations. Seek opportunities to improve or enhance current…
Added 1 hour ago
M
Retail Fragrances Sales Support Associate - Armani/Valentino, Woodbridge Center - Full Time (TEMP)
Macy's
Woodbridge, NJ
- Full-time
Partner with Fragrance Counter Manager or CSX Manager of inventory and other inaccuracies

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