Quality Systems Specialist

Actalent; Philadelphia (Philadelphia County); Híbrido; USD 69 000 - 90 000; Tempo integral

Resumo da oferta

Actalent is seeking a Contract Validation Specialist to join the Quality team in Philadelphia, PA. You will specialize in Computer System Validation, writing and revising validation documentation for Manufacturing and Laboratory work, and reviewing/approving protocols and reports.

You will collaborate with Manufacturing Operations and Laboratory Testing, ensure data integrity, and oversee facility commissioning, change controls, and periodic qualifications in a GMP/GLP environment.

Qualificações

• 3-5 years of relevant experience or equivalent science degree.
• Proficient in Change Control and Deviation processes within GMP/GLP.
• Experience writing and revising validation/qualification documents and SOPs.
• Ability to review and approve qualification and validation protocols and reports.

Responsabilidades

• Write and revise validation documentation focused on Manufacturing and Laboratory work.
• Review and approve qualification protocols, reports, SOPs, investigations, and change documents.
• Provide quality oversight for commissioning/qualification of site facilities and utilities.
• Manage risk assessments, periodic qualifications, and project plans.
• Coordinate with Manufacturing Operations, Laboratory Testing, and outside vendors.

Conhecimentos

Validation

Gmp

Change Control

Deviation

data integrity

data management

computer system validation

Electronic Notebook

Formação académica

Bachelor's degree in Science or equivalent

Ferramentas

LIMS

Electronic Notebook

Descrição da oferta de emprego

Description

-GMP/GLP -Change Control / Deviation -Computer System Validation Candidate will be expected work within the Quality team as the specialist for Computer System Validation. Will be responsible for writing and revising validation documenation focused with the Manufacturing / Laboratory work. This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, investigations, work orders, change documents, reports for projects and maintenance activities Work in a collaborative team setting with quality counterparts that include Manufacturing Operations and Laboratory Testing Provide quality and compliance oversight for the qualification, and validation, of manufacturing, laboratory and testing processes Including, review and approval of qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria Provide quality and compliance oversight for the commissioning and qualification of site facility spaces and utilities Including review and approval of Change Controls, Project Validation Master Plans, Commissioning Test Plans, Qualification protocols, SOP's and Summary Reports Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility Including, review and approval of documentation supporting Plant and Laboratory Maintenance, whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualifications, Project Plans, Master Plans Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks Judgment and problem-solving able to define decision criteria and determine the most appropriate course of action Planning and organizational skills able to establish objectives and schedule tasks/resources efficiently Support technical and quality investigations to resolve issues Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

Skills

Validation, Gmp, Change Control, Deviation, LIMS, Electronic Notebook, data integrity, data management, computer system validation

Top Skills Details

Validation,Gmp,Change Control,Deviation

Additional Skills & Qualifications

3-5 years of relevant experience or equivalent Bachelors degree in a Science related field or equivalent experience Experience in Writing and Revising Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook) Must be proficient in Change Control and Deviation Ability to work effectively as part of a team and to exhibit effective interpersonal skills Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication Must have experience working within a GMP or GLP environment Proficient in Oral & Written communication skills

Experience Level

Intermediate Level

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/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 job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available 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 Philadelphia,PA.

Application Deadline

This position is anticipated to close on Oct 15, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.