Group Leader, Quality Control Environmental Monitoring
Location: Saint Joseph, Missouri
Type: Full Time
Required Education: 4 Year Degree
Internal Number: 219248
Supervise and be responsible for day-to-day operations of environmental monitoring program and ensuring all environmental monitoring is performed in accordance with cGMP, regulatory guidelines, local and corporate procedures, and Company Quality and Compliance Guidelines. Responsible for managing monitoring, trending, investigation processes and departmental personnel. Ensures that non-conformity investigations are thorough and timely to support business KPI's.
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:
Responsible for ensuring environmental monitoring is performed within regulatory/compliance guidelines.
Responsible for trending results of, improving (reducing, refining, replacing, or eliminating) and providing technical support for bio-analytical methods or compliance/support functions within regulatory/compliance guidelines.
Responsible for the maintenance of a clean, safe, orderly and compliant lab or compliant compliance/support group.
Responsible for assuring TOC monitoring of process waters are tested and reported in an accurate and timely manner.
Responsible for keeping updated with product-relevant literature, implementing new/emerging technology and supervising scientists and lab specialists/technicians. Responsible for test schedules, training curricula, operational budget, capital budget, lab and office space, and employee development and evaluation.
Familiar with Outlines of Production, Special Outlines, Supplemental Assay Methods, and US, European and Japanese Pharmacopoeia.
Responsible for reporting data using appropriate regulatory forms, generating/maintaining assay-relevant databases, generating assigned reports and carrying out assigned projects/initiatives.
Perform Company business in accordance with all regulations and Company policies and procedures. Demonstrate high ethical and professional standards.
Bachelor's Degree in related business or scientific field from an accredited institution.
In addition to Bachelor's degree, a minimum four (4) years of experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment. Experience must be inclusive at least three (3) years leading people and/or moderate to complex process improvement and related production projects.
Experience must be inclusive of managing and auditing master receipts, batch records and process order data within relevant SAP/ERP software systems.
Experience in ERP inventory control system(s)is preferred but not necessary.
Experience with word processing, spreadsheets, and database management required.
Demonstrated ability to train others and complete OJT assessments.
Demonstrates the ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
Demonstrated knowledge of Aseptic or related production techniques and equipment.
A working knowledge of cGMP, EU and OSHA Part 11 guidelines as they pertain to implementing process improvements on aseptic production or other production equipment.
Must be detail oriented, able to work with minimal supervision and self-motivated to utilize resources to troubleshoot as needed.
Ability to manage multiple on-going projects with aggressive deadlines.
Strong proofreading skills along with excellent communication and written capabilities.
Must be proficient in MS office applications such as Word, Excel, Outlook, etc.
Must be able to readily learn and quickly become proficient in all software applications utilized for packaging equipment and operations.
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.
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.