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Added 1 hour ago
Director, IT Business Partner and Product Manager
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
That's why we work, on average, a minimum of three days per week from the office
Added 1 hour ago
AP
Director, Cyber Security Detection Engineering
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $169,320 to $253,980 USD / year
Added 1 hour ago
Specialist Pharmaceutical Quality Systems
AstraZeneca Pharmaceuticals LP Company
Rockville, MD
Added 5 hours ago
AP
Associate Regulatory Affairs Director
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $135,182.4 to $202,773.6 USD / year
Added 5 hours ago
AP
Senior Process Engineer, Cell Therapy Process Development
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $96,000 to $144,000 USD / year
Added 5 hours ago
Global Insights Director
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
Added 21 hours ago
US Forecasting Leader – R&I
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
That's why we work, on average, a minimum of three days per week from the office
Added 21 hours ago
Brand Analytics Director
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
Added 1 day ago
AP
MS&T Process Associate Scientist
AstraZeneca Pharmaceuticals LP Company
Frederick, MD
- $90,960 to $136,441 USD / year
Added 1 day ago
AP
MS&T Process Scientist
AstraZeneca Pharmaceuticals LP Company
Frederick, MD
- $112,304 to $168,456 USD / year
Added 1 day ago
I&C Technician II/III - Days
AstraZeneca Pharmaceuticals LP Company
Frederick, MD
Added 1 day ago
AP
Quality Assurance Specialist II
AstraZeneca Pharmaceuticals LP Company
Frederick, MD
- $79,890 to $119,835 USD / year
Added 1 day ago
Senior Stability Specialist, Quality Control
AstraZeneca Pharmaceuticals LP Company
Santa Monica Colorado Avenue, CA
Added 1 day ago
AP
Oncology Account Specialist (Breast) - Minneapolis North, North Dakota, and Western WI markets
AstraZeneca Pharmaceuticals LP Company
Minneapolis, MN
- $132,756 to $228,954 USD / year
Must live within: Minneapolis, MN, Saint Paul, MN, Fargo, ND, or surrounding areas
Added 1 day ago
AP
Oncology Account Specialist (Breast) - Minneapolis South, Iowa, and Southwestern WI markets
AstraZeneca Pharmaceuticals LP Company
Minneapolis, MN · Iowa City, IA
- $132,756 to $228,954 USD / year
Must live within: Minneapolis, MN, Saint Paul, MN, Iowa, or surrounding areas
Added 1 day ago
AP
Senior Medical Science Liaison - Pipeline, Immunology (Mid Atlantic)
AstraZeneca Pharmaceuticals LP Company
Charlotte, NC · Washington, DC · Baltimore, MD · Richmond, VA
- $160,396 to $240,594 USD / year
Must live in the territory or following cites/states: Washington D.C, North Carolina, Richmond, VA, Baltimore, MD
Added 1 day ago
AP
Director, Medical Affairs - Tumor Agnostic
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $193,800 to $289,800 USD / year
Added 1 day ago
AP
Associate Director, Laboratory Space Planning
AstraZeneca Pharmaceuticals LP Company
Cambridge Kendall SQ, MA
- $150,839.2 to $226,258.8 USD / year
Added 1 day ago
US Medical Franchise Head, Hematology
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
Added 1 day ago
AP
Senior Director, Digital Forensics & Incident Response
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $190,957 to $286,435 USD / year
Added 1 day ago
AP
Field Reimbursement Manager - Respiratory - Washington DC
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $161,856 to $242,785 USD / year
The FRM must have a strategic mindset and complex problem-solving skills, to be successful in their role
Added 1 day ago
AP
Field Reimbursement Manager - Respiratory - Pittsburgh, PA
AstraZeneca Pharmaceuticals LP Company
United States
- $161,856 to $242,785 USD / year
The FRM must have a strategic mindset and complex problem-solving skills, to be successful in their role
Added 1 day ago
US Medical Head, Dyslipidemia
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
That's why we work, on average, a minimum of three days per week from the office
Added 1 day ago
Associate Director, Service Contracting
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
That's why we work, on average, a minimum of three days per week from the office
Added 1 day ago
AP
Director, Forward Deployed Security Architecture
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $169,320 to $222,232.5 USD / year
Candidates must reside within commuting distance of Gaithersburg or be willing to relocate for this opportunity

Closed listing

AstraZeneca Pharmaceuticals LP Company

Specialist Pharmaceutical Quality Systems

Rockville, MD, United States

The annual base pay (or hourly rate of compensation) for this position ranges from $83,504.80 - 125,257.20.

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Pay: The annual base pay (or hourly rate of compensation) for this position ranges from $83,504.80 - 125,257.20.
Closing date: Nov 19, 2026
Posting language: English
Posted: Nov 12, 2026

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Original job description

Archived listing. The details below describe a past opening.

As part of Laboratory Management and Stability (LMS) team, the role supports shared core responsibilities such as stability program coordination, sample flow oversight, inventory management, and 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 postgolive 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:

Associate’s degree with 3 years of relevant experience OR bachelor’s degree in Life Sciences, Chemistry, Engineering, Biotechnology, or a related field with at least 2 years of relevant experience
Experience in GMP laboratory operations, pharmaceutical quality systems, manufacturing support, laboratory digital systems, equipment, materials, sample management, stability, or another regulated technical environment
Working knowledge of GMP/GxP, data integrity, ALCOA+, and controlled documentation requirements
Ability to learn and work across multiple LMS processes and laboratory systems, including GQCLIMS, 1Lab, MODA, Businessmap, SAP, or comparable systems
Demonstrated ability to maintain accurate records, manage concurrent assignments, follow issues through closure, and escalate risks appropriately
Effective written and verbal communication, stakeholder engagement, and cross-functional coordination skills

The annual base pay (or hourly rate of compensation) for this position ranges from $83,504.80 - 125,257.20. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted 12-Nov-2026 Closing Date 18-Nov-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.

About employer

More about this job

Skills

Quality control systems
LMS
Inventory management
Documentation
Leadership
Solve ICT system problems
Regulatory compliance
Manage inventory
Kanban
Inspection
Biotechnology
Good manufacturing practices
SAP
Communication skills
Stakeholder management
Sales

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