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Job Title: Quality Control Specialist - Raw MaterialsJob Description

We are seeking a dedicated Quality Control Specialist to develop and manage a QC raw materials testing program that supports commercial manufacturing. The successful candidate will oversee inspection, sampling, and testing of incoming raw materials while ensuring compliance with US and EU GMP requirements.

Responsibilities

+ Oversee the inspection, sampling, and testing of incoming raw materials prior to use in manufacturing, ensuring compliance with US and EU GMP requirements.

+ Ensure materials are sampled according to SOPs, entered into data management systems, and available for use on time.

+ Participate in the qualification of raw materials via external and in-house testing.

+ Serve as subject matter expert in reviewing raw material specifications.

+ Participate in vendor audits as a technical advisor.

+ Oversee daily routine activities of the raw materials group, provide data review, and ensure compliance at all times.

+ Collaborate with Quality Assurance, Manufacturing, Materials Management, external vendors, and other functions to meet internal timelines, testing TAT, and team milestones.

+ Author and maintain required cGMP documentation such as SOPs and guidance documents.

+ Oversee verification of assays at external testing labs.

+ Identify gaps, design collaborative solutions, and implement improvements.

+ Participate in QC laboratory investigations, deviations, and onboarding and qualification of analytical equipment at external testing labs.

Essential Skills

+ Extensive experience with raw material sampling, including handling of powders and liquids, using aseptic techniques.

+ Knowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, FTIR, HPLC, etc.

+ Minimum of 3+ years of hands-on, industry experience managing a cGMP QC laboratory.

+ Knowledge of verification and validation of assays required for raw material testing.

Additional Skills & Qualifications

+ BS in Chemistry, or related field with a minimum of 5+ years of relevant experience within the pharmaceutical industry.

+ Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA).

+ Extensive knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP).

+ Excellent communication and collaboration skills.

+ Attention to detail, highly organized, able to meet schedules and timelines and handle multiple priorities.

Work Environment

The work environment involves collaboration with various departments including Quality Assurance, Manufacturing, Materials Management, and external vendors. The role requires a highly organized individual capable of handling multiple priorities and meeting strict schedules and timelines.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/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 fully onsite position in Redmond,WA.

Application Deadline

This position is anticipated to close on Jun 9, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.