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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
Assistant Stylist
Ulta Beauty, Inc.
Covington, WA
Share the benefits of the guest loyalty program, including credit and the Ulta Beauty app, with guests in the salon and salesfloor.
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 7 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 7 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 7 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 7 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 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 21 mins ago
NURSING STUDENT APPRENTICE IMC (PER DIEM VARIED)
UHS
HENDERSON, NV
…Hospital, a Top Teaching Hospital and earned the “A” Patient Safety Grade from the Leapfrog Group during its last 13 award cycles. In spring 2024, Henderson Hospital was also named one of…
Added 28 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
SO
CDOC Correctional Officer I - Pueblo (SCCF & LVCF)
State of Colorado
Pueblo, CO
- $4,839 to $6,775 USD / month
Contribution Plan plus 401K and 457 plans. Member Contribution Rates. Correctional Officers I-IV qualify as "Safety Officers" and are eligible for increased PERA benefits;
Added 31 mins ago
Plant HR Manager
Toppan Flexible Packaging Inc
Elk Grove, IL
products like transparent high barrier films, pouches, clamshells and trays, utilizing advanced technology to enhance product safety, visibility and environmental sustainability.
Added 41 mins ago
Senior Manager Enterprise Service Management & ServiceNow
SRP
Tempe, AZ
SRP's success is rooted in our employees' happiness, health, and safety. That's why we offer a comprehensive benefits package to meet the needs of our employees and enhance their…
Added 41 mins ago
College Intern - Distribution Scheduling
SRP
Mesa, AZ
SRP's success is rooted in our employees' happiness, health, and safety. That's why we offer a comprehensive benefits package to meet the needs of our employees and enhance their…
Added 41 mins ago
College Intern - Engineering Field Applications
SRP
Phoenix, AZ
The Student Intern Program requires participants to work a minimum of 15 hours per week and up to a maximum of 40 hours per week. Scheduled hours may vary based on departmental needs and…
Added 48 mins ago
M
Beauty Counter Manager - Estee Lauder, Eastridge - Full Time
Macy's
San Jose, CA
- Full-time
As a Counter Manager, you will lead a dynamic team of Beauty Advisors while managing all aspects of a specific cosmetics brand. Your role blends leadership, creativity, and customer…
Added 48 mins ago
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Retail Fragrances Sales Leader, Westland - Full Time
Macy's
Hialeah, FL
- Full-time
…You will also partner with the Sales and Customer Experience Manager and beauty vendors to execute company and store-based events to achieve sales…
Added 48 mins ago
Real-Time Information Center (RTIC) Manager
UWMSN University of Wisconsin Madison
Madison, WI
…design, implement, and potentially lead a transformative public safety program that will support UWPD operations for years to…
Added 48 mins ago
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Beauty Counter Manager - MAC, Southern Park Mall - Full Time
Macy's
Youngstown, OH
- Full-time
As a Counter Manager, you will lead a dynamic team of Beauty Advisors while managing all aspects of a specific cosmetics brand. Your role blends leadership, creativity, and customer…
Added 48 mins ago
M
Beauty Counter Manager - Trend Beauty, Florida Mall - Full Time
Macy's
Orlando, FL
- Full-time
As a Counter Manager, you will lead a dynamic team of Beauty Advisors while managing all aspects of a specific cosmetics brand. Your role blends leadership, creativity, and customer…
Added 48 mins ago
M
Beauty Counter Manager - MAC, Westland - Full Time
Macy's
Hialeah, FL
- Full-time
As a Counter Manager, you will lead a dynamic team of Beauty Advisors while managing all aspects of a specific cosmetics brand. Your role blends leadership, creativity, and customer…

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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