CrawlJobs Logo
GSK Logo GSK · Quality Control

Senior Batch Record Review Specialist

United States, Zebulon · Job Posted May 05, 2026
Apply Position
Job Link Share

Job Description

You will lead batch record review activities to Release product that is manufactured and/or packaged in compliance with regulatory agencies' requirements and company standards. Provide quality guidance to Zebulon Production department to ensure their activities are in compliance with regulatory agencies' requirements and company standards.

Job Responsibility

  • Primarily responsible for review, release, and second check of batch record documentation for compliance to cGMPs, SOPs, and internal and regulatory requirements
  • Coordinates investigations associated with production deviations, as needed
  • Closes Planned Notifications, as needed
  • Assists with issues of NRFT for batch documents
  • Provides quality guidance to production operations, completes work order assessments, and completes atypical comments
  • Communicates effectively with team members, escalates issues to production and quality team/lead, and provides on-call support, as needed
  • Supports self-inspections, internal audits and regulatory inspections
  • Supports Problem Solving/Root Cause Analysis to identify Root Causes and appropriate CAPAs for identified problems
  • Supports OQ training
  • Provides end user support for GMP related documentation corrections
  • Supports continuous improvement processes
  • Supports certificate (CofA, CofC) creation, review and second check verification in alignment with market requirements and GSK standards along with
  • Agree personal objectives from the quality strategy and develops oneself

Requirements

  • High School Diploma plus 4 years relevant experience in the pharmaceutical industry, with a production or quality background. -or- Associates degree plus 2 years relevant experience in the pharmaceutical
  • 3+ years experience in batch record review, quality assurance, or operations within a regulated life sciences environment
  • Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
  • Experience reviewing production, laboratory, and control records for compliance
  • Experience with quality systems such as deviations, CAPA, change control, and lot release

Nice to have

  • Bachelor’s degree in a scientific, engineering, or quality discipline
  • Knowledge of cGMP - FDA and other Regulatory requirements
  • Understanding of continuous improvement tools
  • Understanding of IT applications
  • i.e. MERP, Microsoft office, LIMS
  • Good communication skills
  • Good organizational skills
  • Knowledge of Pharmaceutical Processes
  • Strong attention to detail, clear written communication, and the ability to follow procedures
  • Demonstrated serious commitment to accuracy, integrity and quality
  • Must be able to work independently but also be a strong team player
  • Entry level experience of MERP

What we offer

  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Onsite cafeteria
  • Onsite gym
  • Temperature-controlled climate
  • Licensed, onsite Health & Wellness clinic
GSK - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Batch Record Review Specialist

8 matching positions

Senior Specialist, QA External Manufacturing

The Senior QA Specialist – External Manufacturing is responsible for ensuring qu...
Location
Location
Italy , Pomezia
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
  • 3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
  • Experience in external manufacturing or supplier quality (strongly preferred)
  • Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
  • Strong ability to review complex documentation with accuracy and attention to detail
  • Problem-solving skills with experience in root cause analysis
  • Excellent communication skills to effectively interface with internal stakeholders and external partners
  • Ability to manage multiple priorities and work independently with moderate supervision
  • Familiarity with digital quality tools and AI applications
  • Proficiency in English
Job Responsibility
Job Responsibility
  • Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
  • Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
  • Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
  • Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
  • Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
  • Maintain and update Quality Agreements to reflect current operations and compliance requirements
  • Drive continuous improvement initiatives related to quality systems and external manufacturing performance
  • Support technology transfers, scale-ups, and new product introductions from a QA perspective
  • Partner with Technical Operations and MS&T to enhance processes and product quality
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Senior QA Specialist (CMO Oversight)

Join our client with this QA position and play a key role in maintaining top-tie...
Location
Location
United Kingdom , Uxbridge
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong knowledge of cGMP/GDP regulations for the USA, EU, and international markets
  • Ability to balance business targets with scientific and quality decisions
  • Excellent analytical, problem-solving, and project management skills
  • Strong communication and organizational abilities
  • Experience in developing and executing pharmaceutical quality systems
  • Proficiency in computer systems
  • Degree in a scientific discipline (BSc or equivalent)
  • Technical expertise in chemical, biological, and/or pharmaceutical operations
  • Experience interacting with Health Authorities (e.g., FDA, EMA) and supporting inspections
  • Proven ability to manage quality at external manufacturing sites
Job Responsibility
Job Responsibility
  • Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements
  • Build and maintain strong working relationships with contractors
  • Lead discussions on quality-related topics such as complaints, change control, deviations, and documentation
  • Recommend and oversee quality-related improvements at contractor sites
  • Review batch records, including master production-packaging records and executed batch records, for GMP compliance
  • Manage and monitor change control requests, including evaluation, approval, and progress tracking
  • Support and approve complaint investigations related to external vendors
  • Review, edit, and approve contractor documentation, including validation protocols, reports, and investigations
  • Lead the review of Annual Product Quality Review reports and negotiate improvements with contractors
  • Draft, review, and recommend approval for Quality Agreements
Read More
Arrow Right

Senior Quality Assurance Specialist

CK Group are recruiting for a Senior Quality Assurance Specialist to join a glob...
Location
Location
United Kingdom , Uxbridge
Salary
Salary:
29.00 GBP / Hour
ckgroup.co.uk Logo
CK Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Hold a relevant scientific degree or have equivalent working experience
  • In-depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
  • Ability to build relationships, partnerships and influence stakeholders
  • Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
  • Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
  • Hold entitlement to work in the UK
Job Responsibility
Job Responsibility
  • Responsible for QA vendor oversight
  • Manage contractor quality assurance activities
  • Identify and recommend quality-related improvements
  • Manage change control requests
  • Review batch records
  • Support GMP/GDP site inspections
  • Fulltime
Read More
Arrow Right

Senior Accounts Payable Specialist

The Sr. Accounts Payable Specialist is responsible for the accurate and timely d...
Location
Location
India , Navi Mumbai
Salary
Salary:
Not provided
fugro.com Logo
Fugro
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in finance, Accounting, or related field
  • Understanding of accounting principles and financial reporting
  • Excellent analytical and organizational skills
  • Proficiency in financial software and Microsoft Office Suite
  • Strong communication skills and the ability to handle multiple tasks in a fast-paced environment
  • Detail-oriented with a high degree of accuracy
Job Responsibility
Job Responsibility
  • Enter invoice information into Deltek accurately and efficiently
  • Review and verify invoices and batches for accuracy, completeness, and compliance with company policies
  • Respond to vendor inquiries and resolve any issues or discrepancies in a timely manner
  • Reconcile vendor statements and ensure all accounts are up-to-date
  • Maintain accurate records of all accounts payable transactions and ensure proper documentation
  • Collaborate with other departments to ensure smooth processing of payments and resolve any issues that may arise
  • Assist with month-end closing activities, including preparing reports and reconciling accounts
  • Monitor and analyze accounts payable aging reports to ensure timely payments and identify any potential issues
  • Support internal and external audits by providing necessary documentation and information
  • Continuously improve accounts payable processes and procedures to enhance efficiency and accuracy
What we offer
What we offer
  • Fugro provides a positive work environment as well as projects that will satisfy the most curious minds
  • We also offer great opportunities to stretch and develop yourself
  • By giving you the freedom to grow faster, we think you’ll be able to do what you do best, better
  • We encourage you to be yourself at Fugro
  • So bring your energy and enthusiasm, your keen eye and can-do attitude
  • Fulltime
Read More
Arrow Right

Senior Incident Operations and Optimization Specialist

The Senior Incident Operations & Optimization Specialist for Mainframe & Batch i...
Location
Location
India , Chennai
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Information Technology, Computer Engineering, or a related technical field
  • A minimum of 8+ years of hands-on experience in mainframe operations, batch processing, or enterprise workload automation
  • Proven track record in event management, alert tuning, and incident reduction within complex mainframe and batch environments, with quantifiable results
  • Direct, hands-on experience with modern AIOps and event management platforms is required
  • Deep understanding of mainframe architecture, operating systems, and subsystems
  • Expertise in enterprise workload automation, including job design, scheduling, and dependency management
  • Hands-on experience developing robust automation solutions using relevant scripting languages and modern automation frameworks
  • Proficiency in log analysis, pattern recognition, and using query languages for data analysis on log aggregation platforms
  • Excellent analytical abilities with a systematic approach to troubleshooting complex batch dependencies and failure propagation scenarios
  • Exceptional communication skills with the ability to bridge mainframe/legacy and modern technology teams, influence collaboration, and present technical concepts to diverse audiences
Job Responsibility
Job Responsibility
  • Conduct in-depth analysis of mainframe and batch processing alerts to identify chronic issues, reduce operational noise, and develop strategies to address high-volume incident generators, including recurring job failures
  • Design and implement domain-specific correlation, de-duplication, and suppression rules on AIOps and event management platforms
  • Develop logic that understands mainframe subsystem relationships and cascading batch job dependencies
  • Architect and develop automation playbooks for incident data enrichment, automated job restarts, and self-healing capabilities for common mainframe and batch processing failures
  • Assess monitoring gaps in mainframe and batch environments, proposing enhancements to ensure critical business processes have appropriate alerting coverage and align with enterprise standards
  • Partner closely with mainframe operations, batch scheduling, and application development teams to validate correlation logic, define automation initiatives, and provide expert guidance on modern event management practices
  • Continuously validate the effectiveness of implemented rules and automation
  • Establish feedback loops with operational teams to conduct post-implementation reviews and iterative improvements
  • Fulltime
Read More
Arrow Right

Specialist Quality Assurance

Amgen is one of the world’s leading independent biotechnology companies. For ove...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
  • 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
  • Experience with regulatory audits and inspections
  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
Job Responsibility
Job Responsibility
  • Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
  • Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
  • Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
  • Participate in complex root cause investigations for deviations
  • Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
  • Provides Quality Assurance support in New Product Introduction (NPI) team
  • Coach site Quality Assurance professionals on resolution of complex problems
  • Participate in regulatory inspections, and interact directly with regulatory inspectors
  • Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • All medical related expenses incurred from this medical check shall be borne by the company
  • Fulltime
Read More
Arrow Right

Sr. Specialist I, Product Quality Assurance

The Sr. Specialist I, NC Product Quality Assurance (PQA) will be responsible for...
Location
Location
United States , Durham
Salary
Salary:
140000.00 - 185000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Advanced degree in a scientific discipline with 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
  • Knowledge of aseptic processing, and/or cell and gene therapy is preferred
  • Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
  • Knowledge of global regulations and standards
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team
  • Excellent listening, communication and interpersonal skills with a team focus
  • Consistent delivery of high-quality work
  • Ability to gown and work in a cleanroom environment
Job Responsibility
Job Responsibility
  • Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
  • Provide Quality oversight of QC testing
  • Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
  • Real time review of batch records and labels
  • Review and approval of manufacturing discrepancies and associated CAPA's
  • Communicating lot disposition pending issues to management
  • Aid in the development and ongoing improvement of applicable quality systems for the site
  • identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
  • Review and approve calibration and maintenance work orders and asset inductions
  • Fulltime
Read More
Arrow Right

Specialist Quality Assurance (API)

Amgen is one of the world’s leading independent biotechnology companies. For ove...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
  • 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
  • Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
  • Experience with regulatory audits and inspections
  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
Job Responsibility
Job Responsibility
  • Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
  • Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
  • Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
  • Participate in complex root cause investigations for deviations
  • Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
  • Provides Quality Assurance support in New Product Introduction (NPI) team
  • Coach site Quality Assurance professionals on resolution of complex problems
  • Participate in regulatory inspections, and interact directly with regulatory inspectors
  • Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Fulltime
Read More
Arrow Right