Specialist QA-Drug Substance

Job Description

Job Description

This position supports operations through accurate Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational decision‑making. Requires strong GMP understanding, ability to manage multiple priorities, and capability to work independently.

Functions

• Perform comprehensive Batch Record Review for completeness, accuracy, compliance, and adherence to procedures and GMP.
• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Approve Environmental Characterization reports.
• Approve planned incidents.
• Review manufacturing documentation for GDP, data integrity, accuracy, traceability, and compliance.
• Use SAP for inventory activities: material verification, transactions, reconciliation, status review, and manufacturing support.
• Utilize PAX / Electronic Batch Record (eBR) systems to review and support electronic documentation workflows.
• Participate in DAI meetings and other Quality/operational forums; present information, identify risks, communicate pending items, and support timely decisions.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.
• Own site quality program procedures.
• Serve as designee for QA Manager on local CCRB.
• Lead investigations.
• Lead site audits.
• Review Risk Assessments.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Request Quality participation on incident triage team.
• Represent QA on NPI teams.
• Support automation activities.
• Support facilities and environmental programs.
• Collaborate with higher‑level external resources as needed.

Skills

• Strong project management skills.
• Excellent organizational skills with ability to follow assignments through completion.
• Ability to initiate and lead cross‑functional teams.
• Strong influencing and negotiation skills.
• Deep knowledge in area of expertise.
• Strong understanding of manufacturing, distribution, QA, QAL, validation, and process development processes.
• Ability to interact effectively with regulatory agencies.
• Proficiency in word processing, presentation, database, and spreadsheet applications.
• Strong written and oral communication, facilitation, and presentation skills.
• Ability to work independently and interact effectively across organizational levels.
• Advanced data trending and evaluation skills.
• Ability to evaluate compliance issues.

Requirements

• Doctorate OR
• Master’s + 2 years of directly related experience OR
• Bachelor’s + 4 years of directly related experience OR
• Associate’s + 8 years of directly related experience OR
• High School/GED + 10 years of directly related experience.

Preferred Qualifications (must have)

• Batch Record Review
• GMP / GDP Documentation
• SAP Inventory Management
• PAX / Electronic Batch Records (eBR)
• Manufacturing and Quality Systems
• Inventory reconciliation & material traceability
• Quality event assessment & escalation
• Data Integrity principles

Benefits

• 9-month contract with possible extension
• 3rd Shift (10:00PM- 6:30 AM)