Role Summary The Quality AssuranceSpecialist provides hands-on quality support focused on Document Control, Learning Management System (LMS) administration and training delivery, on-the-floor QA oversight, and deviation/CAPA investigation and approval support. This role will start at the building stage that helps establish and maintain core quality processes, documentation, and training as the site advances toward routine GMP operations for Oral Solid Dosage (OSD) and related manufacturing, and transitioned to system maintenance and improvement after project go-live. The Associate works with limited precedent, exercises independent judgment on quality issues of moderate to diverse scope, and partners closely with manufacturing and operations to embed Right First Time practices.

Key Responsibilities

Document Control

• Own and execute document control activities within the electronic document management system (e.g., Veeva Vault), including drafting, reviewing, routing, approving, issuing, revising, and retiring controlled documents (SOPs, work instructions, forms, job aids, and related quality documentation).
• Ensure documents meet Good Documentation Practices, data-integrity (ALCOA+) expectations, and applicable GMP requirements.
• Maintain document hierarchies, version control, training linkages, and archival in accordance with site procedures.
• Support document change control processes and periodic review schedules.

Learning Management & Training

• Administer and support the Learning Management System (LMS), including curriculum assignment, training record maintenance, completion tracking, and reporting.
• Develop, revise, and deliver GMP, quality-system, and job-specific training materials and sessions for operations and quality personnel.
• Coach colleagues on quality principles and Right First Time behaviors; track training effectiveness and identify gaps.
• Ensure training is completed prior to task performance and that training records are complete, accurate, and inspection-ready.

On-the-Floor QA Oversight

• Provide independent, real-time on-the-floor quality assurance support to manufacturing and operations, including presence during production activities, line clearance, and process monitoring.
• Perform real-time or near-real-time batch record review and support timely resolution of quality issues arising during manufacturing.
• Conduct readiness checks and release of manufacturing areas, equipment, and processes; identify and escalate quality risks.
• Partner with manufacturing, engineering, and other functions to integrate quality requirements into daily operations and promote Right First Time execution.

Deviation / CAPA Investigation & Approval Support

• Support ownership and management of quality events, including deviations, investigations, root-cause analysis, CAPAs, and effectiveness checks.
• Assist in drafting, reviewing, and approving investigation reports and CAPA plans using structured problem-solving approaches.
• Track deviation/CAPA metrics, ensure timely closure, and support effectiveness verification.
• Escalate significant or recurring issues and contribute to trend analysis and continuous improvement.

Additional Responsibilities

• Support internal, client, and regulatory inspections as needed (including document retrieval and subject-matter support).
• Maintain accurate, contemporaneous records consistent with GDP and ALCOA+ principles across electronic quality and document systems.
• Contribute to continuous improvement of document control, training, and quality-event processes as the site quality system matures.

Qualifications

Required

• Bachelor’s degree in a scientific, technical, or related discipline, or equivalent combination of education and relevant experience.
• At least 2-3 years of pharmaceutical or biopharmaceutical quality assurance or quality systems experience, including hands-on GMP manufacturing environment exposure.
• Demonstrated experience with Document Control processes and electronic document management systems (experience with Veeva Vault strongly preferred).
• Experience supporting or administering a Learning Management System (LMS) and delivering or coordinating GMP/quality training.
• Hands-on experience providing on-the-floor QA oversight or real-time quality support in a manufacturing setting.
• Experience supporting deviation investigations, root-cause analysis, CAPA development, and related quality-event processes.
• Strong Good Documentation Practices and data-integrity (ALCOA+) discipline.
• Working knowledge of applicable GMP regulations and the ability to apply them to operational and documentation decisions.
• Excellent written and verbal communication skills with the ability to influence and collaborate across functions.
• Ability to work independently with limited precedent while seeking review at critical decision points.
• Experience operating within electronic quality / document management platforms (Veeva Vault preferred; SAP experience a plus).

Preferred

• Experience supporting a greenfield site, new-facility start-up, or standing up quality processes.
• Experience with multiproduct manufacturing environments and associated controls.
• Quality or auditing certification (e.g., ASQ CQA, CQE).
• Familiarity with risk-management tools and basic statistical concepts.
• Composed and credible in client-facing or inspection settings.
• Awareness of data-integrity and confidentiality risks associated with unvalidated tools or systems.

Key Competencies

• Right First Time mindset: drives quality at the source and coaches others.
• Collaborative, organized, and systematic; brings structure to evolving processes.
• Clear communicator who adapts to technical and non-technical audiences.
• Comfortable contributing in a dynamic, build-stage environment.

Work Environment and Physical Requirements

• Work in a GMP manufacturing environment, including cleanroom and classified areas that may require gowning.
• Periods of standing, walking, and on-floor presence during production.
• Occasional travel for audits or training as needed.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.