Description

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 several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.The SR QC Associate, QC Lab General is 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. This role executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).The SR QC Associate, QC Lab General coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs). This role performs duties under limited supervision and according to standard operating and QC procedures as well as trains other associates and technicians on methods and processes.

Duties & Responsibilities

• Executes independently, with adequate training, three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff.

• Manages and reviews fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning.

• Identifies and implements fundamental improvements to lab processes compliance activities.

• Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).

• 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 improves 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 as needed.

• Performs testing and review within several different analytical technologies.

• Reviews and trends analytical data and compliance processes to identify out of trends.

• Authors routine compliance documents.

• Identifies process anomalies and areas for improvement for operations.

• Provides compliant and smart solutions for moderately complex method and testing issues.

• Coordinates work within the team and cross functionally.

• Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place.

• Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.

• Trains other associates and technicians on methods and compliance.

Requirements for a Sr. QC Associate, QC Lab General

• High School Diploma with six (6) years’ experience of experience in cGMP regulated industry or equivalent. OR Associate Degree with four (4) years’ experience of experience in cGMP regulated industry or equivalent. OR Bachelor's Degree in a science or engineering related field with 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.

• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.

• 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.

• Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed.

• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.

• Strong focus on execution of non-routine analytical methods or processes.

• Strong technical knowledge in analytical methods.

• Ability to work independently with very little supervision.

• Champions problem resolution.

• Knows when to escalate to line management.

• High School Diploma with 5 years of experience in QC of cGMP regulated industry or equivalent preferred.

Requirements for QC Associate, QC Lab General

• High School Diploma with 5 years of experience in QC of cGMP regulated industry or equivalent preferred. OR Associate Degree with 3 years of experience in QC of cGMP regulated industry or equivalent preferred. OR Bachelo's Degree in a science or engineering related field and 1 or more years of experience in QC of cGMP regulated industry or equivalent preferred.

• Experience with performing analytical methodologies 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.

• Strong written and verbal communication skills.

• Experience with computer-based systems.

• Ability 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.

• Proficiency in 1-3 analytical methodologies.

• Technical knowledge in analytical methods.

• Ability to work independently with little supervision.

Requirements for Master QC Associate, QC Lab General

• 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) years of experience in cGMP 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 and document work in a written format applying cGMP/GDP standards.

• 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.

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

• Strong written and verbal communication skills.

• 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.

Compensation Data: This position offers a base salary typically between $44,000 and $84,000 annually.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  

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.