QC Specialist/Senior QC Associate/Master QC Associate, QC Lab General

Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 22, 2021

Job Description:

Description:

QC Specialist/Senior QC Associate/Master QC Associate, QC Lab General

The qualified candidate will be hired at the appropriate level commensurate with education/experience.

Specialist 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.

Associate Description\:

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing. Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility. Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable). 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 maintained activities.  Responsible for quality and compliance activities (authoring of non-routine test methods, specs, plans, reports, forms, SOPs) of moderate complexity. Performs duties under limited supervision and according to standard operating and QC procedures. Serves as QC subject matter expert (SME) representing the department during audits for core topics within group. Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments. May be responsible for one or more QC related compliance (deviations or OOS or CAPAs or CCs) deliverables for routine or core processes.  Trains others as a SME.

Specialist 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. 

Associate Duties & Responsibilities\:

• Executes independently with adequate training non-routine analytical testing methods.  SME in 3-5 analytical methodologies within different scientific principles.  Performs investigational testing and troubleshooting of analytical methods. 

• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Identifies and implements new improvements to lab processes compliance activities.  Responsible for quality and compliance activities (authoring of test methods, forms, SOPs) that are non-routine. Manages and reviews fundamental tasks such as but not limited to\: buffer prep, TCU maintenance, and cleaning.

• Serves as QC subject matter expert (SME) representing the department during audits for core topics within group. Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments.  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.

• Maintains and improve lab areas according to predefined standards (5s).

• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on compliance topics and scientific principles. Establishes training curricula and train others as a SME.

• Supports OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.   Ensures deviations assigned are promptly closed. 

• Responsible for training others.

• Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance.

Specialist 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.

Senior QC Associate Requirements\:

• Bachelors Degree from an accredited institution in a science or engineering related field.
• Two (2) or more years of experience in cGMP regulated industry or equivalent.
• Previous QC Experience preferred. 
• Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
• Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
• Proven experience with technical review, analysis and interpretation of scientific data.
• Strong written and verbal communication skills.
• Experience with computer-based systems and ideally experience with process control systems
• Previous experience to read and understand SOPs and/or methods and document work in a written format applying cGMP/GDP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Strong technical knowledge in analytical methods. Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.

Master QC Associate Requirements\:

• Bachelors degree from an accredited institution in a science or engineering related field, with four (4) years of experience in cGMP regulated industry or equivalent; Or  

• Masters degree from an accredited institution in a science or engineering related field, with one (1) year of experience in cGMP regulated industry or equivalent.

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

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

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

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

• Strong written and verbal communication skills.

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

• Previous experience authoring SOPs, methods, and/or work instructions and document work in a written format applying cGMP/GDP standards.

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

• Clearly understand subject matter and concisely communicate within areas of subject matter expertise.   

• Audit experience preferred.

• Strong technical knowledge in analytical methods.

• Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.  

Eligibility Requirements\:

• Must be legally authorized to work in the United States without restriction.

• Must be willing to take a drug test and post-offer physical (if required)

• Must be 18 years of age or older

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Fremont , QC Specialist/Senior QC Associate/Master QC Associate, QC Lab General, Other , Fremont, California