Specialist QA-Drug Substance

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)