A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The primary responsibilities of this position are to provide management of the Quality Control department which is responsible for testing and release of raw materials used in GMP manufacturing, supporting manufacturing by providing timely results of in-process testing, and conducting final release testing for GMP products, and supporting the stability study program. This position is responsible for supporting efforts to ensure the laboratory is compliant with regulatory requirements including oversight of the training program for QC personnel, maintenance and calibration of instrumentation, reference standard inventory program, and all supportive efforts undertaken in the testing of GMP materials. This position involves direct management and development of Quality Control personnel.
Responsibilities include the direct management of analytical method transfers into the QC laboratory, conducting analytical investigations and testing of intermediate and finished products using HPLC, IR, GC, IC, NMR, TGA, DSC, Karl Fischer, Polarimetry, UV-Vis, other wet lab procedures, and potentially GCMS, LCMS and/or IMS. Experience with writing technical reports is required. Additional responsibilities may include instrument calibration including IQ/OQ/PQ/PM and troubleshooting, generation of cleaning verification/ validation, stability and equipment qualification reports, and other projects as assigned. Responsibilities may include review of analytical results produced by analysis of raw material testing, in-process testing, or data resulting from stability studies.
The Quality Control Supervisor position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
- Demonstrates the ability to provide leadership and organize departmental staff to meet deadlines without compromising quality.
- Demonstrates an advanced understanding of analytical chemistry and laboratory procedures.
- Ensures appropriate technical training is provided for QC personnel.
- May perform routine and non-routine tests as required. Operation of analytical instrumentation including those items specified above, with working knowledge of spectral and chromatographic interpretation and troubleshooting.
- Schedules and coordinates daily work load for laboratory analysts ensuring efficient use of resources with minimum product turnaround times.
- Works in accordance with current GMPs and regulatory requirements, and demonstrates proper laboratory safety and housekeeping practices.
- Uses department resources efficiently and works within departmental budget.
- Responsible for coordinating, overseeing, and reviewing analytical method transfers between Analytical and Quality Control departments.
- Identifies areas for improvement and takes action to undertake them through leadership and delegation to other members of the department.
- Maintains accurate and concise records. Technical report writing.
- Review of analytical data produced for GMP testing.
- Additional duties as assigned.
Who You Are:
- BS/BA in Chemistry or related science
- 4+ years of applicable experience (GMP pharmaceutical quality control laboratory experience is preferred)
- Ability to act in a position of leadership. Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s.
- Competent knowledge of and ability to use Microsoft Word, Excel and Access.
- Excellent organizational, written and verbal communication and interpersonal skills
- Detail-oriented and have excellent communication (written and verbal).
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.