Boehringer Ingelheim Master Associate, Quality Control in FREMONT, California
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.
This is a mid-level staff Quality Control position, performing a variety of semi-routine administrative tasks under general supervision to support business compliance with internal processes and procedures. Incumbent identifies if there are quality problems or deviations of products from standard operating procedures and guidelines, and recommends corrective action to superiors. Performs general Quality Control document review as required for contract lab and BIFI QC testing labs. Incumbent participates in investigations in situations involving deviations of QC samples and testing from governing procedures, processes and regulations; assists with on-the-job training for junior-level staff and serves as a resource to them on simple technical or process questions. Incumbent may lead/manage staff and be assigned to one or more product specific projects - summarizes process/product testing information, both orally and in writing.
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
o Ensures lot release timelines will be met and coordinates testing performed at contract laboratories. This includes, but not limited to, preparation of sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.
o Tests/Inspects components per specification and specified methods.
o Authors/Owns change controls, deviations, laboratory investigations, SOP's and other related documentation.
o Assists other applicable area managers or designees with areas identified for trouble-shooting, for corrective actions related to quality investigations
Coordinate day-to-day operations within lab to ensure materials and products are sampled, aliquoted and distributed within the accepted time frames. Interprets data and resolves technical issues for group. Ensures lot release timelines will be met and coordinates testing performed at contract laboratories. Interfaces with regulatory and client auditors and ensures compliance with current regulations.
Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports. Ensure compliance with current regulations.
Personnel management and training:
Delegates and performs training of personnel to ensure they are properly trained and operating in a safe manner, and in compliance with GMPs.
Performs ongoing evaluation of staff performance, including yearly performance reviews.
Ensures that training and other personal development programs are in place for succession planning and the development of subordinates.
Ensures that performance opportunities are pro-actively managed through the Performance Management system.
Actively participate on cross functional teams (may include facilitation) and share information, as appropriate, with direct reports. Effectively communicate with supervisors, process engineers, and/or managers in other departments and sites.
Interface with other functions and departments:
Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
Assists manufacturing area managers or designees with areas identified for trouble-shooting, for corrective actions related to quality investigations.
Attends and actively contributes in regularly scheduled meetings with Quality Control staff and cross-functional groups.
Implement procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Provide accurate and timely delivery of data and reports to support regulatory filings.
Reviews raw material lot packages and releases RM lots for GMP manufacturing use. Creates and revises RM specifications and coordinates testing.
Process improvement and compliance:
Leads and provides input into continuous improvement projects
Drives the reduction of non-conforming events by performing corrective actions defined by the team.
Maintains specific QC files and database records for process and/or quality improvement efforts.
Communicates deviations in product quality or discrepancies in paperwork to senior colleagues or manager, to ensure these are investigated.
Bachelor's degree from an accredted instituion in Biochemistry, Biology or Life Sciences.
In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals and three (3) to six (6) years’ experience with cGMP required.
Experience in method development desired.
Experience in method qualification, method transfer, and method validation required.
Knowledge of compendial requirements
Knowledge of CFR, USP, and ICH required.
Knowledge of Trackwise, LIMS, and Waters Empower Chromatography Data System desired.
Ability to develop and manage budget plans and forecasts.
Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of 6 years in a leadership position preferred.
May be required to travel nationally.
Performs all work in accordance with good manufacturing practice and regulatory criteria, ensures personnel do the same.
Highly regulated (FDA, DEA, EMEA, Virginia DEQ, EPA) work environment.
Significant technical/operational risk due to increasing legal, regulatory and chemical complexity.
Physical Demands / Surroundings:
Lifting, carrying, pushing or pulling up to 50 pounds occasionally
Frequent periods of sitting, walking, and standing
Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
Occasional low level work, fine finger dexterity/ including grasping or pinching required
Writing and use of a computer keyboard frequently
Occasional use of personal protective equipment
Visual / Hearing Demands :
Color vision and depth perception required.
May require extended hours at a computer screen.
Must be able to read electronic documents of all types.
Hearing acuity required.
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 at http://www.boehringer-ingelheim.com/ and join us in our effort to make more health.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Organization: US-BI Fremont
Title: Master Associate, Quality Control
Requisition ID: 1812054