Specialist QA-Drug Substance

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a QA professional to manage batch records, documentation compliance, electronic systems, and inventory control. Must work independently and handle multiple priorities with strong GMP know‑how.

Responsibilities include batch record review and approvals, CAPA and NC handling, change controls, and lot disposition while supporting audits and risk assessments across manufacturing and QA processes.

Qualifications

• Batch Record Review experience and GMP/GDP documentation
• Strong data integrity understanding and traceability
• Experience with regulatory interactions and audits

Responsibilities

• 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

Project management

Organizational skills

Cross-functional leadership

Influencing and negotiation

Manufacturing and QA knowledge

Regulatory interactions

Computer skills (MS Office)

Communication and presentation

Independent work

Data trending/evaluation

Compliance issue evaluation

Education

Doctorate

Master’s degree + 2 years related experience

Bachelor’s degree + 4 years related experience

Associate’s degree + 8 years related experience

High School/GED + 10 years related experience

Tools

SAP Inventory Management

PAX / Electronic Batch Records (eBR)

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.

• 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

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