Quality Specialist- Weekend/ 3rd Shift

Merck•Saint Louis, MO

About The Position

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: Saturday – Monday 6pm - 6am. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.