Specialist Pharmaceutical Quality Systems

Specialist Pharmaceutical Quality Systems

Summary :

The Pharmaceutical Quality Systems Specialist enables effective adoption integration and compliance of digital tools across Quality Control ( QC ) cell and gene therapy ( CGT ) laboratory operations. The role spans system onboarding stakeholder engagement training change management and issue resolution . Primary systems include 1Lab GQC LIMS and MODA and workflow tools such as Businessmap .

As part of L aboratory M anagement and S tability ( LMS ) team the role supports shared core responsibilities such as stability program coordination sample flow oversight inventory management a nd the management of OOT / OOS deviations CAPAs and continuous improvement initiatives.

Key Responsibilities :

Digital Systems Integration : Lead onboarding and configuration of laboratory digital tools across QC processes ensuring workflows templates roles and access align with operational needs and controlled documentation.

Stakeholder Collaboration : Act as liaison among laboratory staff IT QA and project leadership to gather requirements address concerns align scope and communicate status and decisions.

Training & Documentation : Develop and deliver user-focused training SOPs quick reference guides and controlled templates; conduct readiness assessments and provide post go live support.

Issue Resolution & Enhancements : Troubleshoot system onboarding and usage challenges; coordinate incident triage and enhancement delivery with technical teams; maintain issue / change logs and user feedback loops.

Data Integrity & Compliance : Ensure GxP aligned configuration and use across systems; uphold 21 CFR Part 11 / Annex 11 controls audit trails role-based access validated states and traceability to URS / FRS / test scripts.

LMS Core Operations Support : Support sample flow oversight across QC CGT labs; assist with investigations for OOT OOS deviations and CAPAs; contribute to stability program; and maintain inventory management processes including Kanban room controls min / max levels and timely replenishment to sustain compliant operation .

Audit & Inspection Support : Prepare evidence packages (training records configuration summaries validation status change histories) and participate in internal / external audits and inspections.

Minimum Qualifications :

Associates Degree with 3 years experience OR Bachelors inLife Sciences Chemistry or related field and one year experience implementing or administeringdigital laboratory systemsin GMP environments

K nowledge ofGMP / GxP 21 CFR Part 11 / Annex 11 andALCOA

K nowledge of 1Lab GQC LIMS MODA andBusiness map

Demonstrated ability to design and deliver training author SOPs and lead change management for system rollouts

Excellent stakeholder engagement communication and issue management; comfort with cross- functional coordination

The annual base pay for this position ranges from $82223 to $123334 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participat e in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance wit h the terms and conditions of the applicable plans. Additiona l details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department / team performance and market factors.

Date Posted

08-Dec-2025

Closing Date

14-Dec-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.

Required Experience :

IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1