Change Control Specialist

Actalent; Thousand Oaks (CA); Remoto; USD 62.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental & vision

401(k) Retirement Plan

Time Off/Leave

Descrizione del lavoro

Actalent is seeking a Change Control Specialist External Supply for a fully remote, day-shift role. You will own change control records—from initiation to closure—across packaging, lab chemicals, and medical inventory, acting as External Supply representative with cross-functional teams.

You will drive timely closure of quality records from manufacturing sites nationwide, using TrackWise, while ensuring compliance with pharma/medical device quality and regulatory expectations.

Competenze

• Experience owning change control records start to finish.
• Proficiency with change control for packaging, lab chemicals, and medical inventory.
• Hands-on TrackWise experience for quality records.
• Experience in pharmaceutical or medical device industry with regulatory familiarity.
• Ability to work with minimal supervision while driving change controls to completion.
• Strong organizational skills to manage multiple records and supplier notifications.
• Effective cross-functional communication representing External Supply.

Mansioni

• Own and manage change control records from initiation through closure.
• Coordinate with cross-functional teams to align on change control actions.
• Drive timely closure of quality records from manufacturing sites across the network.
• Assess and implement supplier change notifications and related changes.
• Manage change controls related to packaging, lab chemicals, and medical inventory.
• Collaborate with site and network stakeholders for information gathering and impact assessment.
• Use TrackWise to create, track, update, and close records per procedures.
• Ensure adherence to pharmaceutical or medical device quality and regulatory expectations.
• Work independently with minor supervision and prioritize multiple records to meet deadlines.
• Support sites across time zones with responsive communication.

Conoscenze

Change control ownership

TrackWise usage

Pharma QA

Remote collaboration

Strumenti

TrackWise

Descrizione del lavoro

Job Title: Change Control Specialist External Supply (Remote, Day Shift)

Job Description

The Change Control Specialist External Supply owns and executes all processes related to change control quality records with minimal supervision. In this fully remote, day-shift role, you serve as the key External Supply representative across cross-functional teams and drive timely closure of quality records originating from manufacturing sites across the network. You focus specifically on change controls related to packaging, laboratory chemicals such as media and reagents, and medical inventory control, ensuring that supplier-driven changes are properly evaluated, documented, and implemented.

Responsibilities

• Own and manage change control records from initiation through closure, ensuring complete and compliant documentation throughout the lifecycle.
• Act as the External Supply representative across functional teams to coordinate, communicate, and align on change control activities and decisions.
• Drive timely closure of change control quality records originating from manufacturing sites across the network.
• Own and advance change control records associated with supplier change notifications, ensuring appropriate assessment and implementation of changes.
• Manage change controls that pertain to packaging, laboratory chemicals (including media and reagents), and medical inventory control.
• Collaborate with site and network stakeholders to gather required information, assess impact, and ensure proper execution of change actions.
• Use TrackWise to create, track, update, and close change control records in accordance with established procedures.
• Ensure all change control activities adhere to pharmaceutical or medical device quality and regulatory expectations.
• Work independently with minor supervision, prioritizing and organizing multiple change control records to meet deadlines.
• Support sites in different time zones by providing responsive communication and coordination for change control activities.

Essential Skills

• Proven experience owning change control records from start to finish, including initiation, evaluation, implementation, and closure.
• Demonstrated proficiency with change control processes specifically related to packaging, laboratory chemicals (media, reagents, etc.), and medical inventory control.
• Hands‑on experience using TrackWise for managing change control or quality records.
• Experience in the pharmaceutical or medical device industry, with familiarity in applicable quality and regulatory expectations.
• Ability to work with minor supervision while independently driving change controls to completion.
• Strong organizational skills to manage multiple change control records and supplier notifications simultaneously.
• Effective communication skills to represent External Supply across cross-functional teams and sites.

Additional Skills & Qualifications

• Experience managing quality records originating from multiple manufacturing sites or a distributed network.
• Previous involvement with supplier change notifications and external supplier coordination.
• Experience working in a fully remote environment supporting geographically dispersed teams.
• Comfort working across multiple time zones, including Eastern and Pacific time.

Work Environment

This role is fully remote and operates primarily on a day‑shift schedule. You will support manufacturing sites across the country, with the majority aligned to Eastern Time, and you will maintain some flexibility to support Pacific Time sites as needed. Work is performed in a virtual, technology‑driven environment that relies heavily on electronic quality systems such as TrackWise and standard collaboration tools. You will interact regularly with cross‑functional and site‑based teams through remote communication channels, focusing on coordination of change control activities and timely closure of quality records. Change Control Specialist

Job Type & Location

This is a Contract position based out of Thousand Oaks, CA.

Pay And Benefits

The pay range for this position is $45.00 - $47.00/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)

Application Deadline

This position is anticipated to close on Nov 10, 2026.

Workplace Type

This is a fully remote position.

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.