Quality Control Analyst

At Roche, we advance science so that we all have more time with the people we love.

Your Opportunity

Become a Genentech/Roche member of a collaborative team that creates outcomes that matter for patients, customers and the company. This Direct Materials/Quality Control Inspection position will join the exciting and expansive Quality Control Operations team in Hillsboro Technical Operations. As part of the Direct Materials and Quality Control Inspection team, you are responsible for performing visual inspection, dimensional analysis, and other assays as needed to release raw materials for manufacturing and packaging. As part of the complaints team, you are responsible for conducting sample intake and assessments from customer complaints which may include but are not limited to visual inspection, functional testing, and identification.

Responsibilities:

As part of the Quality Control Organization, general responsibilities include:

• Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures.

• Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.

• Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation.

• Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes.

• Ensure maintenance and calibration of laboratory equipment and systems.

• Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required.

Who You Are:

• You have a B.S./B.A. degree and a minimum of 1-3 years of experience. Degrees are preferably in Biology, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry

• You have raw material testing and secondary packaging inspection release experience.

• You have sound knowledge of cGMPs or equivalent Regulations. A minimum of three years of experience working in a GMP environment is required.

• You possess a strong verbal and written communication skills.

• You possess the ability to interpret and apply quality standards to operational activities.

Work Environment / Physical Demands / Safety Considerations

• Prolonged periods of standing at lab bench top. Frequent lifting (up to 25 lbs), bending, reaching, twisting, climbing stairs. Use of step ladders and push carts required.

• Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

Relocation benefits are not available for this job posting.

The expected salary range for this position based in Oregon $51,000-$75,000 for the Quality Control Analyst level. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.