Senior QC Associate, Potency

Genentech•Hillsboro, OR

13h•Onsite

About The Position

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world. Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. Job Summary: The Quality Control Specialist within the Operations group of the Quality Control Organization supports all activities required of HTO QC, focusing on testing and execution of assignments as assigned by leads, QC specialists, and/or QC management. The QC Specialist plays a meaningful role in maintaining and improving functional operations within QC, enabling the organization to support all manufacturing and business testing needs. This role’s focus is to serve as the QC department’s subject matter expert in Quality Control Operations processes and provide guidance, mentorship, and training to junior analysts. This role works with QC leadership and cross-functional partners on QC-related projects and continuous improvement initiatives. The Opportunity: Coordinate scheduling, logistics, and day-to-day testing activities of analysts and provide overall technical and logistical guidance within their QC focus group/testing pod. 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.

Requirements

Bachelor’s Degree with 5-7 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry. 3-5 years experience with a Master’s Degree or 0-2 years experience with PhD/JD.
Significant potency (bioassay) experience
Sound knowledge of GMP and considerable analytical/QC experience
Experience developing and validating analytical methods
Professional level written and oral communication skills, ability to organize and present information informal and formal group setting
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical method development, qualification/validation, and implementation
Strong analytical intuition, troubleshooting skills (e.g., analytical instrumentation), and problem-solving capabilities
W ork in an office and laboratory environment
Flexibility in problem solving, providing direction and work hours to meet business objectives
Demonstrated ability to work independently to accomplish tasks
Ability to sit, stand and move within work space for extended periods and lift up to 25 lbs
May be required to sit at a computer terminal or laboratory bench for extended periods
Ability to travel to other sites, as required
Work Environment / Physical Demands / Safety Considerations Work in an office and laboratory environment.
Lift up to 25 pounds may be required.
Ability to enter data into a computerized system for up to 30% of your time.
Ability to sit, stand and move within work space for extended

Responsibilities

Coordinate scheduling, logistics, and day-to-day testing activities of analysts and provide overall technical and logistical guidance within their QC focus group/testing pod.
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.