A brief overview
The Manager of Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations within the Quality Control (QC) department. This individual manages and executes coordination and successful stability testing; raw material qualification, testing, and release activities, as well as validation projects. The QC Manager also coordinates testing to be performed by other QC personnel and by contract laboratories. Additionally, this individual supports the Director of QC in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the QC department.
What you will do
- Manage and oversee execution of QC testing including API, raw material, validation & release
- Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
- Establish and revise specifications and sampling plans for raw materials and final product
- Develop and optimize of new and existing analytical methods for qualification and release testing
- Coordinate stability program and the testing to meet stability endpoints, as needed
- Manage 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 reoccurrences
- 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
- Ability to work and communicate effectively with others within the company to ensure timely completion of tasks and projects
Qualifications
- Bachelor's degree with a minimum of 8 years industry experience
- Master's Degree in analytical chemistry or related science field and a minimum of 5 years of Stability/Raw Materials testing and GMP/GLP experience (preferred)
- PhD in Analytical Chemistry or related science field with 2 years industry experience (preferred)
- At least 2 years management/supervisory experience in a GMP manufacturing facility
- Extensive experience in GMP laboratory testing such as 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
Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.
Base Annual Salary Range: $102,240 - $140,580
Placement of new hires in the wage range 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 Platinum Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
