Job Information
Actalent Quality Assurance Specialist - Supplier Quality Management in Seattle, Washington
Job Title: Quality Assurance Specialist - Supplier Quality Management
Job Description
We are seeking a dedicated Quality Assurance Specialist to join our Supplier Quality Management (SQM) group. The successful candidate will support GMP document authoring and revision, as well as supplier management. This role is crucial in ensuring compliance and quality of raw materials supplied for biopharmaceutical/pharmaceutical cGMP manufacturing.
Responsibilities
Create and revise raw material dossiers and material specifications within the electronic document system (eDMS).
Interface with internal and external suppliers/clients to request and obtain required material and supplier documentation, establish supplier-to-supplier agreements, and handle general customer inquiries.
Perform actions associated with Change Control documents, audits, and supplier deviations.
Provide updates to Supplier Records.
Support Supplier Quality projects as needed.
Essential Skills
Minimum of 3 years of experience in biopharmaceutical/pharmaceutical cGMP manufacturing or similar environment.
At least 1 year of relevant supplier quality experience.
Experience communicating verbally and in writing with suppliers and internal personnel.
Strong understanding of cGMP regulatory requirements – ICH, FDA, EMA.
Bachelor's degree in Biochemistry, Biology, Microbiology, Chemistry, or a Scientific/Engineering degree and 1 year of relevant supplier quality experience OR Associate's degree and 3 years of relevant supplier quality experience OR High school diploma/GED and 5 years of relevant supplier quality experience.
Ability to collaborate and communicate cross-functionally.
Proven attention to detail.
Additional Skills & Qualifications
Experience in the pharmaceutical or medical device industry.
Knowledge of FDA and EMA regulations.
Strong organizational skills.
Work Environment
This role can be hybrid. The hybrid option involves working onsite at the Redmond JPOD Facility. The work environment demands high attention to detail, strong written and verbal communication skills, and the ability to work independently and collaboratively. Position is starting as a 3 month contract and there could be potential to extend but no guarantees.
Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr.
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 Seattle,WA.
Application Deadline
This position is anticipated to close on Apr 18, 2025.
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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.