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Fiscal Specialist I - Anderson Area Office
State of South Carolina
Anderson, SC
- $34,476 to $44,778 USD / year
Provide clerical support to the Center Manager regarding SCEIS sales and distribution transactions.
Added 1 min ago
Controller - AF050
Department of General Services (DGS)
Richmond, VA
State Role Title: Financial Services Manager II
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Amazon.com Services LLC
Atlanta, GA
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Program Manager Project Delivery OE
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Operations Office Director, SERS (Administrative Officer 4)
Commonwealth of Pennsylvania
Harrisburg, PA
- $78,925 to $119,844 USD / year
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Added 17 mins ago
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Mid Atlantic Dispatch Assistant Center Manager (Emergency Management Specialist)
Commonwealth of Pennsylvania
Harrisburg, PA
- $60,538 to $92,010 USD / year
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Licensed Psychologist Manager, Corrections - SCI Frackville
Commonwealth of Pennsylvania
Frackville, PA
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Gaithersburg, MD
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Added 32 mins ago
Software/Web Developer (SharePoint) – TS/SCI required
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United States
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Added 32 mins ago
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Help Desk Technician III
GD Information Technology, Inc.
United States
- $23.3 to $29.9 USD / hour
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Added 35 mins ago
Production Assistant
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Added 36 mins ago
Store Manager
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United States
Added 36 mins ago
Sales and Service Technician
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United States
May assist Manager or act as Manager-On-Duty in certain circumstances or to support development.
Added 37 mins ago
Engagement Manager
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Remote, United States
The Engagement Manager is the primary delivery leader and day-to-day client counterpart for assigned engagements. This role combines hands-on program and project management with client…
Added 42 mins ago
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Summer 2027 - Capital Construction Intern - 90398487 - New York
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New York, NY
- $18 to $35 USD / hour
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QUALITY INSPECTOR I - RES
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macon, GA
- $18.27 to $20.75 USD / hour
Identifies non-conforming material and reports to Quality Manager any concerns.
Added 57 mins ago
SENIOR CHILD PROTECTIVE INVESTIGATOR - 60075018
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FT LAUDERDALE, FL
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Monitor patient condition and promptly report changes, concerns, or safety issues to the RN Case Manager, physician, and care team.
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General Manager in Training
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Ocala College Road, FL
As a General Manager in Training (GMIT) you will partner with the restaurant’s current Executive General Manager or General Manager to help with the overall direction, profitability, and…
Added 1 hour ago
THIS POSTING IS INTENDED FOR THOSE REGISTERED TO ATTEND THE SOCIETY OF HISPANIC PROFESSIONAL ENGINEERS CONFERENCE, Oct 28 - 31st in Indianapolis, IN
Medtronic
Boston, MA
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Treasury Sales Associate I - Global Payment Solutions - Healthcare, Higher Education and Not for Profit
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Account Manager/Specialty Account Manager -KRYSTEXXA (Rare Disease) - Boston N, MA
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Account Manager/Specialty Account Manager- Rare Disease - KRYSTEXXA
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Account Manager/Specialty Account Manager- Rare Disease - KRYSTEXXA
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Senior Manager, Commissioning Engineering
Devens
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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…

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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