Specialist, QC Lab General, Onsite, Fremont CA (Fremont, CA, United States, California)

Compensation Details

The base salary range for this position is $88,000 to $132,000. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here .

Description

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, or Raw Materials/Cleaning validation/verification. Provides technical oversight, coordinates and reviews analytical testing of bulk drug substance and drug product in a multi-product facility. SME in 3-5 analytical methodologies within different scientific principles. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Coordinates routine maintenance activities. Identifies and implements fundamental improvements to lab processes and compliance activities. Responsible for quality and compliance activities (new test methods, specs, plans, reports, forms, SOPs) that are new or non-routine.

Performs duties under limited supervision and according to standard operating and QC procedures. Group representative on simple or routine equipment qualifications. Serves as QC subject matter expert (SME) representing the department during audits for 3-5 topics within group. Technical and Quality lead for for routine or platform method transfer/validations/qualifications, verifications and technical assessments. Executes with oversight moderately complex QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls). Managing projects of core, platform processes within Quality.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Provides technical oversight, coordinates and reviews QC analytical testing of bulk drug substance and drug product in a multi-product facility. SME in 3-5 analytical methodologies within different scientific principles. Technical and Quality Lead for routine or platform method transfer/validations/qualifications, verifications and technical assessments.

Identifies and implements new improvements to lab processes and compliance activities. Responsible for quality and compliance activities (new test methods, specs, plans, reports, forms, SOPs) that are new or non-routine. Executes with oversight new, multi-faceted QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls). Serves as QC subject matter expert (SME) representing the department during audits for 3-5 core within group.

Documents work according to cGMP and cGDP.

Adheres to established regulations and follows cGMP established by site.

Reports abnormalities and deviations in a timely and accurate manner.

Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.

Establishes lab areas according to predefined standards (5s). Group representative on simple or routine equipment qualifications. Managing projects of core or platform within Quality.

Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed. Establishes training curricula and train others as a SME. Implements new training procedures and drives continuous improvement.

Leads OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Manages deviation investigations as applicable and provides product quality impact assessment. Ensures deviations assigned are promptly closed. Responsible for training others.

Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Influences and leads inter-departmental meetings with cross functional team members to resolve issues and produce solutions.

This role is not lab focused. It will prioritze the following: 

Change Control, Deviation, CAPA and Action owner

Updates to testing specifications and SOPs.

Monitoring timely release (e.g., incoming materials) and various QC metrics

QC DRD representative for cross functional projects

Authors/updates specifications, SOP, and other GMP-related documents

Owns Change Control, Deviations, CAPAs, Impact Assessments, etc.

Follows-up with appropriate areas to ensure target dates are met.

Owns and/or leads projects (e.g., process improvement, CAPA, etc.)

Requirements

BS/BA from an accredited institution in a science or engineering related field, with four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or

MS/MA from an accredited institution in a science or engineering related field, with two (2) years of work experience in Analytical testing in a GMP regulated industry or equivalent.

Proven experience with technical review, analysis and interpretation of scientific data.

Experience with computer-based systems and ideally experience with process control systems.

Previous experience authoring SOPs, methods, and/or work instructions.

Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.

Experience troubleshooting technical problems and/or equipment.

Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.

Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues.

Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries.

Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.

Track record of troubleshooting and applying the scientific method to solve technical problems.

Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.).

Ability to work as part of a high performing team and collaborate effectively with staff.

Demonstrated ability to lead projects of low complexity.

Desired Skills, Experience and Abilities

Experience in quality and cGMP environment.  Knowledgeable in deviations, change control, and CAPAs.

Pharmacopeial knowledge (e.g.,USP, Ph. Eur), ICH

Problem-solving capabilities (e.g., analytical, recognizes data trends, etc.).

Detail oriented with a right first time mindset.

Communication and collaboration skills.  Works with cross-functional teams.

Open to change and drives improvements/efficiencies.

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