A brief overview The 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 do:- Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing
- Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
- Establish and revise specifications and sampling plans for IPC, raw materials and final product
- Develop and optimize new and existing analytical methods for qualification and release testing
- Coordinate stability program and the testing to meet stability endpoints, as needed
- Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules
- Write, review, and approve QC Standard Operating procedures (SOP's) as needed
- Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
- Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences
- Manage external test laboratories for contract testing of raw materials and other related testing
- Review test data for completeness and accuracy
- Provide timely responses to internal and external inquiries
- Stay abreast of new developments in analytical technologies
- Contribute to improvements in laboratory operations to increase efficiency and GMP compliance
Qualifications:- Bachelor's degree in a relevant scientific field with a minimum of 8 years' industry experience
- Master'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 testing
Creativity to solve technical and compliance problems
Comply with good housekeeping and safety practices
Experience in writing standard operating procedures (SOP's) and test methods
Excellent written and oral communication skills
Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one's time
Ability to drive projects to success under time constraints
Communicate effectively and ability to function well in a team environment
Base salary range:
Manager:
$109,396 - $164,095Sr. Manager: $133,304 - $183,293 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards:
We 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 Employer As 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.
