US_Quality Control Technician I_CO

Title : Sr. QC Analyst

Location : Hillsboro, OR

Duration : 12 Months

Available Shifts : Sunday to Wednesday and Wednesday to Saturday, 4x10's

• (onboarding and initial training period may require Mon-Fri, 5X8s, shift)

Day : 6 : 30am to 5 : 00pm

Swing : 11 : 30am to 10 : 00pm

Job Description :

healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Client.

Client, a member of the Client group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to Client and develop medicines for people with serious and life-threatening diseases. To solve the world's complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.

Responsibilities include Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Client / Client 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.

The QC Analyst must be able to Interpret 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 as required.

Responsibilities :

Competencies.

Requirements :

Work Environment / Physical Demands / Safety Considerations :

Strong verbal and written communication skills, ability to organize and present information in a formal and informal group setting.

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