Specialist QA- 35657 (3rd Shift)

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen in Juncos, PR seeks a QA professional to support Quality Assurance programs under minimal supervision, focusing on batch record review, GDP compliance, and electronic systems management.

Responsibilities include leading investigations, site audits, change controls, CAPA, and cross-functional collaboration to ensure product quality and patient safety in a GMP-regulated environment.

Qualifications

• Doctorate or Masters with directly related experience.
• Bachelor's degree with 4+ years of directly related experience.
• Associates with 8+ years of directly related experience.
• High school/GED with 10+ years of directly related experience.

Responsibilities

• Perform comprehensive Batch Record Review to ensure completeness, accuracy, compliance, and adherence to approved procedures and GMP requirements.
• Review manufacturing documentation for 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.
• Demonstrate experience with PAX / Electronic Batch Record (eBR) systems to review, assess, and support electronic manufacturing documentation and workflows.
• Participate actively 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 and apply 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 strong 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, enabling management and cross-functional teams to make informed decisions.
• Identify potential issues proactively and demonstrate a solution-oriented and continuous-improvement mindset.

Skills

Batch Record Review

GMP / GDP Documentation

SAP Inventory Management

PAX / eBR

Data Integrity

Quality Systems

Inventory Reconciliation

Leadership & Collaboration

Risk Assessment

Communication Skills

Education

Doctorate or Masters

Bachelor's + 4 years

Associates + 8 years

High school/GED + 10 years

Tools

SAP

eBR Systems

Job description

SUMMARY:

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

FUNCTIONS:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on 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 orMasters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS:

• The position is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational decision-making. The role requires a strong understanding of GMP requirements, the ability to manage multiple priorities in a fast-paced manufacturing environment, and the capability to work independently with minimal supervision.
• The ideal candidate demonstrates strong judgment, effective communication, attention to detail, and the ability to clearly communicate critical information to cross-functional teams and management.

Key Responsibilities

• Perform comprehensive Batch Record Review 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.
• Demonstrate experience with PAX / Electronic Batch Record (eBR) systems to review, assess, and support electronic manufacturing documentation and workflows.
• Participate actively 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 and apply 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 strong 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, enabling management and cross-functional teams to make informed decisions.
• Identify potential issues proactively and demonstrate a solution-oriented and continuous-improvement mindset.

Core Qualifications & Competencies

• Technical
• 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

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.

SKILLS:

• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• 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.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Amgen Values/Leadership Practices.

WORK METHODOLOGY:

• Full- time job
• Full on-site job
• Location: Juncos, PR
• Expected hiring month: September 2026
• Initial contract term: 11monthsfor the first contractwith a high possibility of extension based on performance and budget.
• Number of openings: 1
• 3rd Shift & Non-Standard Shift
  • Available to work 5:00 pm to 5:30 am.
  • Weekends and overtime may also be required.
• Professional services contract