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 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 Manufacturing Quality & Systems Specialist position, located in St. Louis, MO, USA, supports our cGMP Commercial Manufacturing Facilities, which manufacture APIs as well as Excipients.
Your Role: The Manufacturing Quality & Systems Specialist is responsible for ensuring compliance while executing manufacturing protocols, consistent with current Good Manufacturing Practices (cGMP), and ensuring the accuracy of documentation. This role will be a department lead in Root Cause Analysis, Change Control, and cGMP document review.
ESSENTIAL JOB FUNCTIONS:
- Perform production operations and responsibilities in the presence of the Customer, as well as effectively communicating production status to Customer.
- Review production documentation and perform regular Quality Walk-throughs during manufacturing events
- Write and revise Master Manufacturing Formulas; Prepare and review Operating Procedures to ensure compliance with FDA and cGMP guidelines
- Author root cause analysis (RCA) reports as well as Corrective & Preventative Actions (CAPAs)
- Lead change control initiatives for both Equipment and Process changes
- Provide technical leadership during the manufacturing process.
- Perform necessary analytical tests and evaluate results during a production operation.
Who you are: To succeed in this role, you should have hands-on experience in a cGMP Manufacturing Quality role, preferably in a ‘QA on the Manufacturing floor’ setting. As a custom API contract manufacturing organization, our Specialists must have strong technical and communication skills.
- Education: B.S. in Biology, Chemistry, or Chemical Engineering preferred.
- B.S. >5 years relevant cGMP API manufacturing and/or quality experience
- Professional Skills, Qualifications and Experience:
- This position requires a strong technical and quality background. Direct interaction with Quality Assurance, Quality Control, Project Management, and customers is expected; Therefore good communication skills (oral and written) are essential.
- Our Manufacturing Specialists must have the ability to apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice.
- Our Manufacturing Specialists are expected to identify potential safety, quality and compliance risks associated with technology transfer and scale-up, and propose solutions to mitigate risk prior to GMP Manufacturing operations.
- Customer interaction adds an additional element to this position. The customer judges our Company based on interactions with our employees, deciding if continual business opportunities will be offered to MilliporeSigma. This element adds an additional challenge to to the employee in this position to represent MilliporeSigma with the highest level of professionalism and responsibility. Experience with customer interaction is desired.
- Intermediate knowledge in chemistry, biology, biochemistry, and math, as well as an understanding of current Good Manufacturing Practices is required.
- Familiarity with analytical instrumentation and cGMP process equipment is desired.
- This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.
- Travel Requirements: None to Minimal travel
- Pre-Employment testing requirements:
- Physical Requirements (PPE, lifting): - Requires the ability to lift and carry up to 80 pounds while wearing personal protective equipment, including respirators, for an extended time.
- cGMP Manufacturing Environment: The manufacturing of APIs require ISO8 clean rooms. Specific Personnel Protective Equipment (PPE) is required when working in classified rooms.
- Work schedule: Shift work may be required during manufacturing campaigns
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.