Quality Specialist

Actalent

United States

Híbrido

USD 41 000 - 44 000

Tempo integral

14 dias+

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Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision
401(k) Retirement Plan
Life Insurance

Resumo da oferta

Actalent is seeking a Quality Specialist to support U.S. Nutrition & Health contract manufacturing quality by coordinating updates to finished product testing specifications. The role requires extensive experience with specification management, regulatory compliance, data integrity, and collaboration with contract manufacturers.

This is a remote, full-time contract based out of Bridgewater, NJ. The position emphasizes lifecycle management, dashboard development, and process improvements within

Qualificações

  • Minimum of 13 years of experience with specification management, quality systems, data maintenance, or release testing requirements in SAP, Veeva, PLM, TraceGains, or comparable systems.
  • Minimum of 13 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry.
  • Knowledge of U.S. regulatory and GxP requirements applicable to Nutrition & Health products, including FDA 21 CFR Part 111, FDA 21 CFR Part 117, HACCP, and product release controls (preferred).
  • Understanding of FDA 21 CFR Part 111 and 117 requirements and how they translate into finished product, raw material, packaging, and release testing specifications.

Responsabilidades

  • Coordinate, track, and execute updates to finished product testing specifications for externally manufactured Nutrition & Health products.
  • Maintain specification update activities in alignment with applicable U.S. regulations, quality management system requirements, brand standards, and agreed contract manufacturer controls.
  • Create, route, track, and close specification update records, change controls, intake requests, and related tasks in the applicable system of record.
  • Maintain a master tracker for U.S. Nutrition & Health contract manufacturing specification updates, including priority, owner, affected SKU or material, contract manufacturer, system status, and implementation date.

Conhecimentos

Specification management
Quality systems
Data maintenance
Release testing
Industry experience

Formação académica

Bachelor's degree

Ferramentas

SAP
Veeva
PLM
TraceGains

Descrição da oferta de emprego

Job Title: Quality Specialist

Job Description

The Quality Specialist supports U.S. Nutrition & Health contract manufacturing quality by coordinating, tracking, and executing updates to finished product testing specifications for externally manufactured products. This role ensures that specification updates align with approved formulas, label claims, product release requirements, microbiological and contaminant standards, market-specific requirements, and contract manufacturer capabilities. The position drives specification compliance, data integrity, and continuous improvement under the direction of contract manufacturing quality in a remote, full-time capacity.


Responsibilities


  • Coordinate, track, and execute updates to finished product testing specifications for externally manufactured Nutrition & Health products.

  • Maintain specification update activities in alignment with applicable U.S. regulations, quality management system requirements, brand standards, and agreed contract manufacturer controls.

  • Create, route, track, and close specification update records, change controls, intake requests, and related tasks in the applicable system of record.

  • Maintain a master tracker for U.S. Nutrition & Health contract manufacturing specification updates, including priority, owner, affected SKU or material, contract manufacturer, system status, and implementation date.

  • Coordinate specification updates with contract manufacturers to confirm feasibility, testing capability, method alignment, certificate of analysis format, release criteria, and effective-date readiness.

  • Support updates related to microbiological requirements, contaminant limits, allergens, claims, certifications, net content, packaging requirements, shelf life, and market-specific criteria.

  • Maintain controlled specification records, supporting rationale, approval evidence, and contract manufacturer alignment documentation in SharePoint or the applicable quality system.

  • Develop dashboards, reports, and routines that improve visibility to overdue updates, compliance gaps, launch risks, and implementation bottlenecks.

  • Perform other specification quality duties as assigned to support overall contract manufacturing quality objectives.

  • Maintain compliance with applicable safety, environmental, and information-management requirements when handling controlled documents, records, samples, or contract manufacturer information.

  • Support paperless and efficient specification workflows where possible, while ensuring records remain controlled, traceable, and audit-ready.

  • Flex work hours or work extended hours when required to support urgent specification updates, launch readiness activities, regulatory requests, release holds, or contract manufacturer implementation needs.


Essential Skills


  • Minimum of 13 years of experience with specification management, quality systems, data maintenance, or release testing requirements in SAP, Veeva, PLM, TraceGains, or comparable systems.

  • Minimum of 13 years of experience in the food, dietary supplement, medical nutrition, pharmaceutical, nutraceutical, or contract manufacturing industry.

  • Knowledge of U.S. regulatory and GxP requirements applicable to Nutrition & Health products, including FDA 21 CFR Part 111, FDA 21 CFR Part 117, HACCP, and product release controls (preferred).

  • Understanding of FDA 21 CFR Part 111 and 117 requirements and how they translate into finished product, raw material, packaging, and release testing specifications.

  • Familiarity with specification lifecycle management, data integrity, change control, document control, and dietary supplement or food quality system expectations.

  • Quality assurance experience, including quality control, GMP, QMS, and audit support.

  • Project management skills to manage multiple specification updates, priorities, and timelines.

  • Excellent written and oral communication skills, including the ability to document technical rationale and communicate requirements clearly to contract manufacturers.

  • High proficiency with Microsoft Excel and Office Suite, with the ability to manage trackers, dashboards, and structured data reviews.

  • Experience using SAP, Veeva, PLM, TraceGains, or comparable quality systems (preferred).


Additional Skills & Qualifications


  • Bachelors degree or equivalent experience in Quality, Food Science, Regulatory, Chemistry, Microbiology, Nutrition, Supply Chain, or a related technical field (preferred).

  • Ability to interpret and apply U.S. regulatory and GxP requirements to Nutrition & Health product specifications and release controls.

  • Strong attention to detail and commitment to data integrity and documentation accuracy.

  • Ability to collaborate effectively with contract manufacturers and internal stakeholders to align on specifications and implementation plans.

  • Comfort working in a structured, systems-driven environment with controlled documents and records.

  • Ability to develop and maintain dashboards and reports that provide clear visibility into specification status, risks, and compliance.

  • Willingness to work extended hours or flex schedule when needed to support time-sensitive specification changes and product launches.


Work Environment

This is a remote position based out of Bridgewater, NJ, offering a full-time schedule, Monday through Friday from 8:00 a.m. to 5:00 p.m. Work is performed in a professional, technology-enabled environment with extensive use of quality and data systems such as SAP, Veeva, PLM, TraceGains, SharePoint, and Microsoft Office tools. The role focuses on managing controlled documents, electronic records, and specification workflows in a paperless or paper-light environment, ensuring that all records remain traceable and audit-ready. Collaboration occurs virtually with contract manufacturers and internal quality, regulatory, and supply chain teams, with occasional need to flex hours or work extended days to support urgent specification updates, launch readiness, regulatory requests, release holds, or implementation needs.


Job Type & Location

This is a Contract position based out of Bridgewater, NJ.


Pay and Benefits

The pay range for this position is $30.00 - $32.00/hr.


Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.


Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:



  • Medical, dental & vision

  • Critical Illness, Accident, and Hospital

  • 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available

  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)

  • Short and long-term disability

  • Health Spending Account (HSA)

  • Transportation benefits

  • Employee Assistance Program

  • Time Off/Leave (PTO, Vacation or Sick Leave)


Workplace Type

This is a hybrid position in Bridgewater,NJ.


Application Deadline

This position is anticipated to close on Oct 16, 2026.


About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.


The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.


If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.


San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.


Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.


Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

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