Work Location: St. Louis, Missouri
Shift: Yes
Department: LS-SC-UYKQB Cherokee Quality Assurance 2
Recruiter:Guadalupe Barragan
Hiring Manager: Ashlynn Messick
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma, the QA Specialist will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7.
- Shift: Sun-Tues 2pm-12am (FLOAT) this position will be required to fill for other off-shifts (noted above) when someone is on vacation.
- Participate in QA on the floor activities in manufacturing.
- Review batch records while in process during manufacturing events.
- Review batch records postproduction for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
- Review and approval of QC data to support batch disposition.
- Execution of batch and raw material disposition decisions.
- Provide quality oversight and support for new product introductions as primary quality point of contact.
- Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols and other controlled documents under a Quality Managed System (QMS).
- Release activities for cGMP product and raw materials.
- Review and approval of master packaging formulas, master shipping records, and master manufacturing formulas.
- Document and label issuance activities.
- Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
- Monitor product for quality related issues and collaborate on resolution.
- Respond to quality-related customer questions, as needed.
Physical Attributes:
- Environmental conditions will vary depending on specific job responsibilities; typically, 10%-30% Office Environment, 70%-90% Production, QC, Packaging.
Who You Are
Minimum Qualifications:
- Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline.
- 5+ years quality experience.
OR
- Master’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline.
- 2+ years quality experience.
Preferred Qualifications:
- Knowledge of ICHQ7 and API knowledge and/or experience.
- TrackWise and SAP experience.
- Proficiency in MS Word, MS Excel, MS PowerPoint and the ability to learn and operate other specific application software.
- Excellent communication (verbal & written) and customer interfacing skills.
- Experience writing technical documentation & reports.
- Ability to simultaneously manage multiple tasks/priorities.
- Good problem-solving, time management and negotiating skills.
- Capacity for independent work.
- Data analysis, presentation, and experimental design knowledge.
RSREMD
- Pay Range for this position: $62,500.00- $93,700.00.
- The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
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.
