Title: Specialist QA – ProQN657
Location: Juncos, PR
Eligibility: Open only to Puerto Rico Residents
Positions: 1
Work Schedule: Onsite; availability for Non-Standard Shifts and Third Shift
Contract Duration: 10 months
Summary
Our client is seeking a Specialist QA to support Quality Assurance and Manufacturing operations with minimal supervision. The role will focus on accurate Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational decision-making.
The ideal candidate will have a strong understanding of GMP requirements and the ability to manage multiple priorities in a fast-paced manufacturing environment while working independently. Strong judgment, effective communication, attention to detail, and the ability to clearly communicate critical information to cross-functional teams and management are essential.
Preferred Candidate Profile
A results-driven professional with experience in GMP-regulated pharmaceutical or biotechnology manufacturing, capable of combining Quality compliance, operational knowledge, electronic systems expertise, and sound judgment.
Key Responsibilities
- Perform comprehensive Batch Record Reviews to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
- Review manufacturing documentation for Good Documentation Practices (GDP), data integrity, accuracy, traceability, and procedural compliance.
- Utilize SAP for inventory-related activities, including material verification, inventory transactions, reconciliation, status review, and manufacturing support.
- Utilize PAX / Electronic Batch Record (eBR) systems to review, assess, and support electronic manufacturing documentation and workflows.
- Participate in DAI meetings and other operational or Quality forums by presenting relevant information, identifying risks, communicating pending items, and supporting timely decisions.
- Evaluate operational situations using appropriate decision-making and risk-based thinking, escalating issues when required based on potential impact to product quality, compliance, operations, or patient safety.
- Support the assessment and communication of Quality events, documentation discrepancies, process concerns, and operational issues.
- Work effectively under pressure while maintaining accuracy, compliance, and appropriate prioritization of critical activities.
- Manage assigned responsibilities independently and with minimal supervision, demonstrating ownership, accountability, and appropriate follow-through.
- Collaborate effectively with Quality, Manufacturing, Supply Chain, Warehouse, and other cross-functional teams.
- Maintain effective communication across shifts and functions to ensure critical information, pending activities, risks, and decisions are clearly transferred.
- Organize complex information and communicate it clearly, concisely, and accurately to support informed decision-making by management and cross-functional teams.
- Proactively identify potential issues and demonstrate a solution-oriented and continuous-improvement mindset.
Core Qualifications & Competencies
- Batch Record Review
- GMP / GDP Documentation
- SAP Inventory Management
- PAX / Electronic Batch Records (eBR)
- Manufacturing and Quality Systems
- Inventory reconciliation and material traceability
- Quality event assessment and escalation
- Data Integrity principles
Leadership & Operational
- Sound decision-making
- Risk-based thinking
- Ability to work under pressure
- Ability to work with minimal supervision
- Strong ownership and accountability
- Effective prioritization and time management
- Problem-solving skills
- Cross-functional collaboration
Communication
- Strong written and verbal communication skills
- Ability to present information during DAI and operational meetings
- Clear communication of risks, priorities, pending items, and decisions
- Ability to translate complex operational information into concise, actionable messages for different levels of the organization
Functions
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality participation on incident triage teams.
- Approve Environmental Characterization reports.
- Release sanitary utility systems.
- Approve planned incidents.
- Represent QA on the NPI team.
- Lead investigations.
- Lead site audits.
- Own site Quality program procedures.
- Serve as designee for the QA Manager on the local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support Facilities and Environmental programs.
- 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.
Education
- 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.
Competencies & Skills
- Project management skills
- Strong organizational skills, including the ability to follow assignments through to completion
- Ability to initiate and lead cross-functional teams
- Strong skills in leading, influencing, and negotiating
- Strong knowledge in area of expertise
- Ability to collaborate and coordinate with higher-level outside resources
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development
- Demonstrated ability to interact with regulatory agencies
- Strong word processing, presentation, database, and spreadsheet application skills
- Strong written and oral communication, facilitation, and presentation skills
- Ability to work independently and effectively interact with various organizational levels
- Advanced data trending and evaluation
- Ability to evaluate compliance issues
- Demonstrated alignment with our client’s values and leadership practices