Responsible for the supervision, scheduling, monitoring, related auditing and record review activities of all Quality Assurance personnel. Oversees all work processes of the Quality Assurance personnel, including but not limited to deviations, investigations, and issues encountered the personnel’s job related functions. Ensures manufacturing areas and records have been audited and reviewed for compliance to cGMPs, SOPs and customer requirements to support company goals.
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:
Coordinates the processing of TRK’s in Trackwise including but not limited deviations, investigations, protocols etc. and Hold/Release notices of the areas audited by assigned Quality Specialists.
Works closely with Production and Quality Management to resolve significant Quality issues in a timely manner which may require real-time and/or follow up activities. Authorized to suspend manufacturing operations when situations warrant and recommends remediation activities. Determines when and if it is appropriate to resume operations.
Ensures priorities and communications are handled appropriately. Monitors manufacturing and release schedules and schedules quality activities so deadlines for release of batch records are met. Ensures quality activities are performed in conformance to requirements following cGMPs, BVL SOPs and customer requirements.
Provides oversight and support of direct report activities, ensuring the on-the-floor auditing and documentation is accurate, reflective of the process and/or product being produced, and is completed and submitted to the final record compilation and review group/stage in a timely manner so that market and customer needs are met. Ensures all communication of status and issues of each record is accurate and updated daily to all BVL departments involved in release. Ensures all manufacturing issues/documentation associated with each batch produced in assigned area have been resolved prior to release and are compliant with cGMPs and SOPs.
Assists with customer/regulatory inspections or audits. Ensures timely response to post-release customer observations by coordinating review with both manufacturing and Quality areas.
Responsible for anywhere between 1-5 Quality personnel.
Conducts staff meetings to implement departmental policies, clarify goals, motivate employees, develop teamwork, exchange ideas, and supply information. Counsels staff individually regarding career development, objectives, goals, as well as issues and concerns regarding performance.
Reviews, approves and assists in execution of protocols for investigations/deviations.
Maintains integrity and security of batch records during manufacturing and review activities by keeping all records appropriately filed and locked in a secure area. Ensures procedures are in place to enforce that records once received by Quality Assurance are maintained and tracked. Ensures procedures for transferring of manufacturing records to Final Record Compilation & Review group are in place and followed.
Bachelor’s degree in a math or science related field preferred or a minimum of 3 years of applicable GMP experience in a QA position and/or equivalent years experience in a related field also considered as deemed appropriate by QA Management.
Thorough understanding of GMP regulations and various regulatory body expectations.
General understanding of aseptic manufacturing, auditing practices, validation concepts, laboratory controls, and investigation writing.
Good computer skills, including proficiency in MS Word, MS Excel, and MS Access
Ability to simultaneously manage multiple tasks/priorities
Excellent problem solving and communication skills
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
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