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Boehringer Ingelheim Vetmedica.Inc.
QA Manager, Biological Operations
Job Location: Saint Joseph, MO
Department:
QA/QC / Other
Shift:
Full Time
Our Culture - Come Discover Us:
Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects.
Competitive benefit and compensation programs reflect the Company's high regard for its employees and enhance each person's ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company's uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today's complex business challenges. We are an equal opportunity employer. M/F/D/V.
Job Description:
QUALIFICATIONS:
Extensive experience in the Vaccine /pharmaceutical USDA/EU regulated industry
Strong theoretical and practical knowledge of computerized process and information systems
Incumbent must have good knowledge of microbiological and chemistry principles, validation, solid mathematical abilities, good attention to detail
Working knowledge of cGMPs, GLPs and USDA regulations. EPA exposure helpful
Advanced degree in biological sciences. PhD preferred or equivalent education and experience
At least 5-10 years of experience in the cGMP/USDA vaccine manufacturing or pharmaceutical industry
DUTIES & RESPONSIBILITIES:
Overall direction for the development and administration of systems and procedures to assure that all cGMP, USDA, EU etc. requirements are met prior to release raw materials, labeling, components and finished product for use or distribution of the following
Overall direction and leadership for the development, control and administration of GXP related QA document systems for the company. Included are procedures and practices for developing, reviewing, approving, and implementing quality standards, deviations, PQR, change control, batch documentation, validation reports/protocols training documentations etc. The incumbent has final approval authority for all of the above
Administrate and provide overall leadership for QA Operations departmental activities such as budgeting, personnel - includes safety, employee development, training appraisals and general supervision, and resource utilization - includes: overtime, contract labor and headcount administration
Primary responsibility for assuming proper manufacturing control via: Proper development control, and compliance to Master Production Records/Outlines of productions/Dossiers/export requirements for distribution and compliance, audit and approval role for a cGMP compliant product and process validation program, proper conduct of annual product batch record reviews.
How To Apply:
Boehringer Ingelheim Vetmedica.Inc.
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