Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKMC Cherokee Manufacturing GMP
Recruiter: Guadalupe Barragan
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma, as the Buffer Formulations Operator at our Cherokee Site/ 3300 S. Second Ave, St Louis, you will be expected to safely execute, develop new approaches, and perform support operations in a cGMP regulated environment for the support of API (Active Pharmaceutical Ingredients) manufacturing teams, including maintaining equipment, preparation of solutions, staging of equipment and supplies, and other various manufacturing support activities. The primary responsibility will be creating buffer formulations in support of Drug Substance manufacturing.
The Formulations Operator is a key role within our GMP Manufacturing/Operations Systems & Support team. Expectations is to ensure "Compliance" and "Readiness" within our GMP Operations teams, ultimately enabling high manufacturing success.
- Prepare buffer formulations in support of Drug Substance manufacturing, with a focus on safety and quality.
- Maintain cleanliness of manufacturing areas including cleaning during regularly scheduled intervals (daily, weekly, etc.).
- Execution and documentation of daily tasks following current Good Manufacturing Practices (cGMPs).
- Utilize quality approved operating procedures and document activities with adherence to GDP standards.
- Maintaining logbooks in accordance with the procedure.
- Safely and properly dispose cleaning and process waste per approved procedures.
- Maintain safe stock of supplies and gowning utilizing Kanban system.
- Aid/input in quality deviations as needed.
- Perform safety inspections and necessary preventive maintenance.
- Assist in preparation of and follow procedures to ensure compliance with applicable Safety and Quality guidelines.
- Develop and assist in the implementation of process improvement, safety, quality, and 6S
- Training of new employees on department policy, procedure, and processes.
- Assist in a department functions and work closely with department supervisor to ensure daily department operating goals are achieved.
- This is a first shift role that may necessitate working evenings and weekends to fulfill production needs.
- Stand for extended periods of time.
- Lift, push, and or pull up to 50lbs.
- Wear mask, safety shoes, gloves, Tyvek suits, respirator, and related personal protective equipment.
Minimum Qualifications:
- High school diploma or GED.
- 6 months experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT).
- Prior experience in an API manufacturing environment.
- Strong mechanical aptitude.
- Demonstrated process improvement experience.
- Familiarity with FDA, EMA, and other regulatory standards.
- Demonstrated knowledge and experience in various computer skills, including Windows (Word, Excel, PowerPoint, etc.
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.