Senior Specialist Pharmaceutical Quality Systems
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Job Location:
Rockville, MD - USA
Hourly Salary:
$ 98725 - 148088
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Senior Specialist Pharmaceutical Quality Systems
Summary:
The Pharmaceutical Quality Systems Senior Specialist supports Quality Control (QC) cell and gene therapy (CGT) laboratory operations by ensuring the reliability and readiness of laboratory infrastructure. The role emphasizes equipment lifecycle management cross-functional coordination and compliant efficient operations.
As part of LaboratoryManagement andStability (LMS) team the role supports sharedcoreresponsibilities such as stability program coordinationsample flow oversightinventory management and the management of OOT/OOS deviations CAPAs and continuous improvementinitiatives.
Key Responsibilities:
Laboratory Infrastructure: Manage laboratory infrastructure utilities and maintenance programs to ensure operation efficiency.
Equipment & Asset Management: Own preventive maintenance and calibration schedules; manage qualification status (IQ/OQ/PQ) lifecycle tracking service history and audit readiness.
Cross-Functional Coordination: Interface with Facilities Validation and IT to address utilities environmental monitoring instrument integration and computerized system support whilemaintainingQC ownership of readiness.
Vendor Oversight: Schedule escort and oversee external service vendors; ensure safety GMP compliance and complete service documentation.
Digital Systems Administration: Admin/power user forGQCLIMS 1LabBusinessmapandMODA.
LMS Core Operations Support: Support sample flow oversight across QC CGT labs;assistwith investigations for OOT OOS deviations and CAPAs; contribute to stability program; andmaintaininventory management processes including Kanban room controls min/max levels andtimelyreplenishment to sustain compliant operation.
Audit & Inspection Support: Prepare evidence packages (training records configuration summaries validation status change histories) andparticipatein internal/external audits and inspections.
MinimumQualifications:
Associates degree and 8 years of experience ORBachelors inLife Sciences Engineering or related fieldand 6 years experienceinGMP laboratory operations(CGT/biologics preferred);experience with equipment qualification and computerized system compliance
Strong knowledge of1Lab GQCLIMS MODAandBusinessmap
Strong knowledge ofGMP/GxP21 CFR Part 11/Annex 11 andALCOA
Audit/inspection support experience
Demonstrated vendor management and cross-functional coordination
Excellent stakeholder engagement communication and issue management
The annual base pay for this position ranges from $98725 to$148088. 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 toparticipatein 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 coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails 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-2025Closing Date
14-Dec-2025Our 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:
Senior 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
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
