Specialist QA-Drug Substance

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 130,000; Part time

Job summary

Biopharma-Consulting-Jad-Group is seeking a QA professional to support Batch Record Review, GMP/GDP documentation, and systems management. You will manage multiple priorities, review validation reports, and support CAPA investigations, change controls, and incident triage.

The role requires strong GMP knowledge, independence, and ability to collaborate with cross-functional teams and regulatory agencies. This is a 9-month contract with potential extension, based in Puerto Rico.

Qualifications

• Must have advanced degree or equivalent related experience as listed.
• Experience in GMP/GDP documentation and regulatory interactions.
• Familiarity with equipment, validation, and process development workflows.

Responsibilities

• Perform comprehensive Batch Record Review for completeness, accuracy, and GMP compliance.
• Review and approve product MPs and change controls.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits and risk assessments; participate in DAI and NPI teams.

Skills

Project management

Organizational skills

Cross-functional leadership

Influencing and negotiation

Data trending & evaluation

Regulatory interaction

Documentation & QA

Independent work

Education

Doctorate

Master’s + 2 years related experience

Bachelor’s + 4 years related experience

Associate’s + 8 years related experience

High School/GED + 10 years related experience

Tools

SAP

PAX/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)