1463 GMP QA Compliance Specialist
Job Summary:
The QA Specialist – QA Compliance supports and maintains the site Quality Management System (QMS) by ensuring local procedures align with the company’s Group Quality Standards and applicable GMP regulations.
The role leads structured gap assessments, identifies and drives remediation activities, coordinates implementation of required changes, and partners with Global Quality and cross‑functional stakeholders to sustain compliance and continuous improvement.
Key Accountabilities:
Lead gap assessments of local QMS procedures against Group Quality Procedures and Corporate Standards.
Coordinate updates to local SOPs, work instructions, and controlled documents.
Track implementation and drive completion to defined timelines; escalate risks as needed.
Partner with process owners and SMEs to establish and implement compliant solutions.
Support Change Control, CAPA, Deviations, and Quality Risk Management activities.
Support internal audits and regulatory inspections; assist in remediation and follow‑up.
Monitor compliance metrics and prepare management reports using trending and visual KPI management.
Develop and deliver training and guidance on new or revised quality procedures.
Drive continuous improvement and harmonization of quality system processes.
Qualifications:
Education:
Required: Bachelor’s degree in life sciences or equivalent experience.
Preferred: Master’s degree or equivalent experience (business, engineering, or related).
Experience:
3–5 years in quality assurance or GMP environment (0–3 years in CGT manufacturing acceptable).
Relevant quality or GMP certifications a plus.
Required Skills & Competencies:
Knowledge of cGMP and applicable regulations.
Experience with Change Control, CAPA, deviations, audits, and risk management.
Project management skills: presentations, stakeholder liaison, meeting facilitation.
Familiarity with Trackwise, SAP, and document management systems preferred.
Strong planning, organizing, and decision‑making abilities; detail oriented.
Ability to manage multiple priorities and meet tight timelines under pressure.
Self‑motivated, good written and verbal communication, team player, customer focused.
Demonstrates agility, business acumen, collaboration, drive for results, and leadership accountability consistent with core competencies.
Essential Job Functions & Working Conditions:
Work schedule: regular office hours.
Environment: office setting; may require occasional site presence and gowning.
Physical: primarily office/admin tasks; occasional standing, walking, bending; occasional lifting up to 50 lbs.
Safety: must follow job safety procedures, attend required training, and promote safety.
Mental demands: frequent stakeholder interaction, analytical and critical thinking required.
The hiring range for this position is $69 to $79.58 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.