QA MES Specialist
Women In Bio, Marietta, PA, United States
Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.
Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping to improve the health of millions of people.
The supply chain is vital to bringing our innovations to patients quickly, efficiently and effectively. Technology is transforming how we manufacture, enabling faster, higher quality and scaled product supply.
Position Summary
You will lead quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. You will partner with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness.
Responsibilities
Lead MES quality activities including system configuration reviews, electronic batch record checks, and system change control support.
Review MES‑generated records and reports to confirm completeness, data integrity, and compliance with procedures.
Support investigations of deviations linked to MES or digital systems, performing root‑cause analysis and tracking corrective actions.
Partner with validation and IT to ensure MES changes link to DQ/IQ/OQ/PQ or equivalent validation steps and documentation.
Coach manufacturing and lab teams on good documentation practices, electronic record keeping, and system use on the shop floor.
Maintain inspection‑ready MES records and contribute to quality KPI trending and continuous improvement initiatives.
Support readiness for internal and external audits, provide clear documentation, and act as a subject‑matter contributor during inspections.
Manage supplier and third‑party quality expectations for MES vendors and integrators, ensuring timely resolution of issues.
Basic Qualification
Bachelor’s degree in a technical, scientific, or quality‑related field, or equivalent experience.
2+ years experience in quality, manufacturing, or digital systems within a regulated life sciences environment.
Experience with MES, electronic batch records, or other manufacturing execution or electronic quality systems.
Experience supporting change control, deviations, CAPA, or document management in a regulated environment.
Preferred Qualification
Bachelor’s degree in engineering, life sciences, information systems, or a related field.
Experience with MES implementation, configuration, or validation in pharma or biotech.
Understanding of DQ/IQ/OQ/PQ or equivalent validation lifecycle and how it ties to quality systems.
Experience with electronic document management systems or quality management software.
Formal training in root‑cause analysis methods or investigation techniques.
Ability to coach and influence operational teams and to present technical information clearly.
Strong written and verbal communication skills and the ability to work across functions.
Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including data integrity principles.
Work Arrangement
This role requires on‑site presence for hands‑on MES support, validation activities, and shop‑floor coaching—minimum 4 days per week on site.
We are an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.
Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping to improve the health of millions of people.
The supply chain is vital to bringing our innovations to patients quickly, efficiently and effectively. Technology is transforming how we manufacture, enabling faster, higher quality and scaled product supply.
Position Summary
You will lead quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. You will partner with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness.
Responsibilities
Lead MES quality activities including system configuration reviews, electronic batch record checks, and system change control support.
Review MES‑generated records and reports to confirm completeness, data integrity, and compliance with procedures.
Support investigations of deviations linked to MES or digital systems, performing root‑cause analysis and tracking corrective actions.
Partner with validation and IT to ensure MES changes link to DQ/IQ/OQ/PQ or equivalent validation steps and documentation.
Coach manufacturing and lab teams on good documentation practices, electronic record keeping, and system use on the shop floor.
Maintain inspection‑ready MES records and contribute to quality KPI trending and continuous improvement initiatives.
Support readiness for internal and external audits, provide clear documentation, and act as a subject‑matter contributor during inspections.
Manage supplier and third‑party quality expectations for MES vendors and integrators, ensuring timely resolution of issues.
Basic Qualification
Bachelor’s degree in a technical, scientific, or quality‑related field, or equivalent experience.
2+ years experience in quality, manufacturing, or digital systems within a regulated life sciences environment.
Experience with MES, electronic batch records, or other manufacturing execution or electronic quality systems.
Experience supporting change control, deviations, CAPA, or document management in a regulated environment.
Preferred Qualification
Bachelor’s degree in engineering, life sciences, information systems, or a related field.
Experience with MES implementation, configuration, or validation in pharma or biotech.
Understanding of DQ/IQ/OQ/PQ or equivalent validation lifecycle and how it ties to quality systems.
Experience with electronic document management systems or quality management software.
Formal training in root‑cause analysis methods or investigation techniques.
Ability to coach and influence operational teams and to present technical information clearly.
Strong written and verbal communication skills and the ability to work across functions.
Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including data integrity principles.
Work Arrangement
This role requires on‑site presence for hands‑on MES support, validation activities, and shop‑floor coaching—minimum 4 days per week on site.
We are an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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