Sr. Quality Control Analyst
Genentech, Hillsboro, OR, United States
Senior Quality Control Analyst – Operations Group
The Senior Quality Control Analyst within the Operations group of the Quality Control Organization supports all activities required of HTO QC, focusing on testing and execution of assigned tasks by group leads, senior analysts, and/or QC management. The Senior QC Analyst plays a meaningful role in maintaining functional operations within QC, enabling the organization to support all manufacturing and business testing needs.
Responsibilities
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.
Qualifications
5-6 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry OR
3 years of experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry with a Bachelor's Degree
Has proficiency gained through technical training and regular application, on-the-job experience
Work Environment, Physical Demands & Safety Considerations
Work in an office and laboratory environment
Lift up to 25 lbs may be required.
Ability to sit, stand, and move within work space for extended periods
May be required to sit at a computer terminal for extended periods.
Working location is Onsite.
The expected salary range for this position based on the primary location of Oregon is $52,640 to $97,760. 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
Relocation benefits are provided
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.
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The Senior Quality Control Analyst within the Operations group of the Quality Control Organization supports all activities required of HTO QC, focusing on testing and execution of assigned tasks by group leads, senior analysts, and/or QC management. The Senior QC Analyst plays a meaningful role in maintaining functional operations within QC, enabling the organization to support all manufacturing and business testing needs.
Responsibilities
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.
Qualifications
5-6 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry OR
3 years of experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry with a Bachelor's Degree
Has proficiency gained through technical training and regular application, on-the-job experience
Work Environment, Physical Demands & Safety Considerations
Work in an office and laboratory environment
Lift up to 25 lbs may be required.
Ability to sit, stand, and move within work space for extended periods
May be required to sit at a computer terminal for extended periods.
Working location is Onsite.
The expected salary range for this position based on the primary location of Oregon is $52,640 to $97,760. 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
Relocation benefits are provided
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.
#J-18808-Ljbffr