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Job Title: Manufacturing AssociateJob Description

Performs review of documents, records, and procedures supporting the release of clinical and commercial GMP products and participates in the development of GMP operations, as assigned. Performs review of validation documentation, periodic reviews of validated systems, and/or procedures, as assigned.

Responsibilities

• Compile and perform lot file review including assessment of manufacturing records, test method data, and deviations for GMP compliance to enable lot release.

• Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations.

• Review certificates of analysis.

• Evaluate discrepancies noted during batch record reviews.

• Conduct GMP incident/deviation reviews.

• Apply the principles of good quality systems and GMP, as assigned on a daily basis.

• Create and revise standard operating procedures (SOPs) as needed.

• Assist with the reporting and presentation of department metrics, including input into reports to Management, annual product quality reviews, and process improvements.

• Assign part and lot numbers and maintain logs.

• Conduct periodic reviews of validated systems.

• Review validation deliverables for compliance with company policies and procedures.

Essential Skills

• Knowledge of cGMP and applicable FDA regulations.

• Detail-oriented team player.

• Ability to independently review documentation and identify gaps.

• Experience reviewing GMP documentation including protocols, reports, batch records, and data.

• Ability to maintain logs and schedules.

• Ability to organize lot documentation, validation plans, protocols, data, and reports in a controlled document system.

• Must be able to organize information in a consistent and retrievable manner.

• Ability to work effectively in a fast-paced environment.

Additional Skills & Qualifications

• Laboratory experience.

• Experience with high throughput operations.

• Time management and organizational skills.

• Ability to hit the ground running.

• Team player.

• Ability to work independently.

• Punctuality.

• Strong communication skills.

• Willingness to learn.

Work Environment

You will be working in a fast-paced environment that requires strong organizational skills and attention to detail. The role involves handling and organizing sensitive documentation and maintaining logs and schedules. The work environment will be compliant with GMP standards and you will be expected to adhere to strict protocols and procedures.

Pay and Benefits

The pay range for this position is $28.50 - $28.50/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 Bothell,WA.

Application Deadline

This position is anticipated to close on Mar 31, 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.