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Added just now
Chief Engineer - - Little Rock, AR
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…building systems, guest rooms, public spaces, and back-of-house operations are maintained to the highest standards while providing an exceptional experience for guests and…
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Resident/Associate Attorney Spring '27
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…legal teams, helping them successfully transition to an MFL Associate Attorney position upon passing the…
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…legal teams, helping them successfully transition to an MFL Associate Attorney position upon passing the…
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- Up to $110,700 USD / year
…legal teams, helping them successfully transition to an MFL Associate Attorney position upon passing the…
Added just now
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…legal teams, helping them successfully transition to an MFL Associate Attorney position upon passing the…
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AstraZeneca

Specialist Pharmaceutical Quality Systems

Rockville, MD, United States
Rockville, United States

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

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Job details

Pay: The annual base pay (or hourly rate of compensation) for this position ranges from $83,504.80 - 125,257.20.
Apply by: May 11, 2027
Posting language: English
Posted: Nov 12, 2026

Original job description

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.

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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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Work requirements

Jobs in the United States