Quality Assurance/Quality Control Inspector

Exciting opportunity to join a leading Marysville manufacturer serving the Biotech and Pharmaceutical industry. Enjoy working in a world class facility with significant room to grow! We are hiring for both the Quality Associate I and II.

Please note: We are a non-tobacco use company and work in a clean room environment with a strict hygiene policy. Tobacco users will not be considered.

Located in a brand new 45,000 square foot headquarters building just blocks off Smokey Point Boulevard.

The Quality Associates will provide world class quality and regulatory compliance to current ISO 9001:2015 standard and cGMP principles. Responsibilities can include nonconformance investigations and closures, external and internal audit support, document change control, Cleanroom Environmental Monitoring activities, Inbound and Outbound material verification and release, in-process Quality checks and other Quality related duties as assigned.

Essential Duties and Responsibilities: Including but not limited to the following:

Maintain Quality System documents in compliance with ISO 9001 and cGMP principles

Perform end-to-end quality control including incoming materials, in-process materials, and final QC material inspection activities.

Serve as a Subject Matter Expert Representative during customer audits.

Open and support non-conformance investigations.

Participate in process improvement initiatives for the Quality Department.

Assist in development and maintenance of a company training program.

Desired Education:

QA I-A High School education with emphasis and an interest in the STEM field.

QA II-Bachelor’s degree or higher in life sciences/engineering discipline preferred.

Desired Experience:

QA-I- A substantial interest in building a long term career for a leading manufacturer. A tie or connection the sciences whether it be via HS lab classes or work experience in retail, distribution or food service. Attitude is key for this hire!

QA II- No experience in biopharmaceutical or medical device industry required, however past experience in complex manufacturing and quality work is helpful. 1 year of work in a "quality assurance" supporting FDA regulated products.

Knowledge and experience working with ISO 9001

Prior Environmental Monitoring experience preferred

Ideal Knowledge, Skills, and Abilities:

Knowledge of ISO standards and cGMP principles

Knowledge of change control, nonconformance, and environmental monitoring

Ability to analyze and interpret data

Desire to acquire new knowledge and training

Strong collaboration and communication skills, written and electronic.

Knowledge and experience with Good Documentation Practices

Proficient with written and electronic record keeping

ASQ certification or equivalent a plus

We offer a competitive benefits, excellent work environment, growth and more! Healthcare Insurance, 13 days of PTO, on the job education and training.

Compensation will range between $48,000 and $70,000 annually depending on candidate qualifications, education and work experience.

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Thank you,