QA Lead Training and Documentation

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Your Role:This position provides QTS and electronic training systems administrative management for site operations and provides strategic direction for site wide training program. 

Major Position Activities & Responsibilities:• Sets strategy for and provides guidance and support to all department supervisors/managers and training administrators in employee training related functions including new hire training curriculum development, assignments, ongoing trainingassignment additions due to job or role change, as well as removal of personnel/assignments from the system upon employee termination of employment• Provides training system support as Subject Matter Expert (SME) during internal and external audits. Runs requested reports and/or field training system related audit questions.• Works as a training system Super User to troubleshoot and find resolution to system discrepancies, unlock system quizzes, and field other coordinator’s inquiries or issues• Coordinates rollout and implementation of system updates to training system• Develops, enhances, manages, and ensures compliance of the training system, training curricula

Task Assessment Checklists (TAC’s), and User Groups for all areas, but with specific responsibility for the following departments: Manufacturing, Maintenance, Materials Management, Supply Chain, Technical Support, Validation, and Process Development

• Assigns and monitors training status to ensure company-wide compliance with training requirements and schedule. Generates and distributes past due training reports.• Arranges and organizes company-wide training sessions, including New Hire GMP training, quarterly GMP training, safety briefings, department trainings and lunch and learn sessions• Leads and coordinates training system improvement projects across various site departments QTS Document Coordination• Coordinates and executes site/departmental controlled document revisions via QTS document change order process and facilitate connectivity of updated document revisions between QTS and ComplianceWire electronic training system.• Ensures compliance of document revision requests including creation of new and revision and/or retirement to existing Standard Operating Procedures (SOP’s), batch records, forms, raw material specifications, in-process specifications, finished good specifications, job descriptions, protocols, user requirement specifications (URS), training matrices, and organizational charts in support of process changes, installation of new equipment, new personnel/personnel job changes and new product transfers• Verifies and confirms all documents routing per an NC, ISS or Change Plans are correctly referenced prior to routing• Manages multiple departments document change orders and facilitate related spreadsheet, which allows for improved flow of contingent documents to be routed, reviewed/approved, assigned training, and made effective• Supports documentation and training efforts on capital projects and tech transfer projects relative to new clinical, commercial products, and contract manufacturing opportunities• Leads cross functional teams to develop new documented procedures for business systems and administrative functions• Leads cross functional efforts for manufacturing and technical document improvement projects,

Who You Are:

Minimum Qualifications:• B.S. in Chemistry, Biology, Engineering, Business Management, or related discipline required• Minimum 3 years of experience in pharmaceutical/biotech operations in technical support, training, new product transfer, manufacturing operations, or similar capacity• In-depth knowledge of GDP and current GMP requirements (US and European), FDA guidelines, and industry standards is required

• Strong verbal and written communications skills are required

Preferred Qualifications:• Previous experience coordinating project teams is preferred• Working knowledge of process equipment, manufacturing operations, process control systems, process hazards and safety• Advanced computer skills (spreadsheets, word processing, PowerPoint presentations and databases)• Employee must be self-motivated, highly organized, and conscientious• Effective interpersonal skills are required to interface with internal and external customers and auditors• Must be able to work and make decisions independently as well as with a team• Must thrive in technically and mentally demanding situations• Must be well-organized to effectively coordinate multiple projects concurrently• While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. The employee is occasionally required to sit; walk; stoop, kneel, bend, crouch, or crawl, talk or hear. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision

Please see Job Description

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html