Manager / Sr. Manager, Quality Control

A brief overviewThe Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department.What you will doManage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testingSupervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnelEstablish and revise specifications and sampling plans for IPC, raw materials and final productDevelop and optimize new and existing analytical methods for qualification and release testingCoordinate stability program and the testing to meet stability endpoints, as neededManage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedulesWrite, review, and approve QC Standard Operating procedures (SOP’s) as neededEvaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testingInvestigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrencesManage external test laboratories for contract testing of raw materials and other related testingReview test data for completeness and accuracyProvide timely responses to internal and external inquiriesStay abreast of new developments in analytical technologiesContribute to improvements in laboratory operations to increase efficiency and GMP complianceQualificationsBachelor's degree in a relevant scientific field with a minimum of 8 years’ industry experienceMaster's degree in a relevant scientific field with a minimum of 5 years’ industry experience (preferred)PhD in a relevant scientific field with a minimum of 2 years’ industry experience (preferred)1-3 years’ management experience (preferred)1-3 years’ experience in managing projects (preferred)Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.Thorough knowledge and understanding of analytical chemistry, including USP materials testingCreativity to solve technical and compliance problemsComply with good housekeeping and safety practicesExperience in writing standard operating procedures (SOP’s) and test methodsExcellent written and oral communication skillsExcellent computer knowledge, including Microsoft Word, Excel, Power Point and AccessAbility to effectively organize, multitask, and work in a fast-paced, deadline driven work environmentAbility to communicate in a proactive and solution-focused manner, including keeping management aware of potential issuesDetail oriented with the ability to troubleshoot and resolve problemsAbility to work independently and manage one’s timeAbility to drive projects to success under time constraintsCommunicate effectively and ability to function well in a team environmentBase salary range:Manager: $109,396 - $164,095 Sr. Manager: $133,304 - $183,293Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.Total RewardsWe offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.Bachem Americas is an Equal Opportunity EmployerAs an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.