Quality Procedures and Training Specialist

HOW YOU’LL MAKE AN IMPACT: Act as a document administrator managing DCR (document change request) routing and supporting controlled document lifecycles – including creation/revision (collaboration), review and approval, effective release, periodic review, obsolescence and archival activities. Train new hires and existing users on MasterControl/Alchemy navigation, DCR creation, document review and approval, and training completion; maintain current quick-reference guides, job aids, and troubleshooting resources following system or process updates.

Job Title: Quality Procedures and Training Specialist
Location: Torrance, CA or Lake Forest, CA or Winston-Salem, NC
Duration: 6 months

Duties:
ROLE AT A GLANCE:
The Quality Procedures & Training (QPT) Specialist administers controlled documents and role-based training requirements within the MasterControl Document and Training module and Learning Management Systems. This role supports the lifecycle of all controlled documents and training matrices, and manages Document Change Request (DCR) routing within the MasterControl to maintain accurate, current, and audit-ready records, in compliance with GxP requirements, applicable ISO standards and 21 CFR Part 11/111/117.

HOW YOU’LL MAKE AN IMPACT:

• Act as a document administrator managing DCR (document change request) routing and supporting controlled document lifecycles – including creation/revision (collaboration), review and approval, effective release, periodic review, obsolescence and archival activities.
  • Format, proofread, and standardize documents, including SOPs, Work Instructions, Forms, Policies, Templates, and Whitepapers, to promote consistency, ensure regulatory compliance, and alignment across controlled content.
  • Review and maintain metadata such as Document InfoCard and packet information, including but is not limited to document type, lifecycle, vault, ownership, approver roles, legacy document references, attachments.
  • Coordinate document collaboration and approval activities; verify that required reviews are complete, resolve routing issues, and ensure approved native files and supporting records are retained in designated repositories.
• Act as a training by creating and maintaining courses, exams, job codes, trainee assignments, group sign-offs, and associated training records.
  • Develop, maintain, and periodically review training matrices with functional managers and process owners to align required training with job titles, roles, departments, locations, and regulated responsibilities.
• Monitor document and training compliance, prepare routine and adhoc reports, investigate assignment or record discrepancies, and support audits, inspections, CAPA, change control, and continuous improvement activities.
• Provide guidance and support to document creators, collaborators, approvers, managers, trainees, and local Document or Training Administrators on approved QPT processes and MasterControl/Alchemy requirements, as needed.
• This role works closely with Quality Assurance, Quality Management Systems, department leaders, document owners, subject matter experts, approvers, and training stakeholders across Worldwide Operations. Success requires responsive service, clear communication, and disciplined coordination to move documentation and training activities forward without creating operational bottlenecks.
• Support training completion verification through read-and-understand acknowledgments, comprehension assessments, group sign-off records, and on-the-job training documentation, as applicable.
• Partner with Quality and cross-functional stakeholders to develop KPIs, remediate audit findings, support CAPA activities, and resolve document or training nonconformances, as needed.
• Train new hires and existing users on MasterControl/Alchemy navigation, DCR creation, document review and approval, and training completion; maintain current quick-reference guides, job aids, and troubleshooting resources following system or process updates.
• Additional duties as assigned.

TEAM DYNAMICS:

• Works within the Global Quality and Technical Services team, functional managers, process owners, subject matter experts, HR, and site or regional Document and Training Administrators globally. The role operates in a collaborative, deadline-driven environment requiring strong ownership, service orientation, and attention to detail.

LEADERSHIP AND SUPERVISORY RESPONSIBILITIES:

• N/A. This position does not have direct supervisory responsibility but provides process guidance, user training, and day-to-day coordination across document and training workflows.

QUALIFICATIONS FOR SUCCESS: (Skills, background, and experience required for success)

Education

• Bachelor’s degree in Science, Engineering, Quality, or a related technical discipline.

Experience

• 3 years of hands-on experience in QA document control and training administration within a regulated environment, including experience with document and training/learning management systems. Experience with MasterControl Documents and Training modules is strongly preferred.

Skills/Certifications

• Working knowledge of 21 CFR Parts 11, 111, and 117; ISO/IEC 17025;
• Advanced Microsoft Office skills, particularly Word styles, multilevel numbering, document layout, templates, Excel tracking, and PowerPoint.
• Excellent organizational and analytical skills, with the ability to manage multiple workflows, deadlines, and detailed records accurately.
• Clear written and verbal communication skills with the ability to guide cross-functional stakeholders and explain controlled processes.
• Must be able to see, hear, speak and write clearly in order to communicate with employees and/or other customers
• Manual dexterity required