Senior Quality Specialist - Computer Systems Validation

MilliporeSigma; Rockville (MD); Sur place; USD 81 000 - 121 000; Plein temps

Avantages offerts par ce poste

Health insurance

Paid time off (PTO)

Retirement contributions

Résumé du poste

MilliporeSigma is seeking a Senior Quality Specialist – Computer Systems Validation to audit and improve validation documentation within the Quality Assurance team. You will ensure compliance with 21 CFR Part 11 and related regulatory standards while collaborating with global cross-functional teams to achieve on-time system go-lives and continuous improvement initiatives.

The role requires a Bachelor's degree and 6+ years' experience in pharma/biotech validation, with strong writing skills and

Qualifications

• Bachelor’s degree required in any discipline.
• 6+ years' experience in validation or QA validation in pharma/biotech.
• Strong technical writing and regulatory documentation skills.

Responsabilités

• Review and audit computerized system validation deliverables per 21 CFR Part 11 and Annex 11.
• Review validation docs including requirements, validation plans, IQ/OQ/PQ, risk assessments, tests, and trace matrices.
• Collaborate with global teams to meet go-live and enhancement targets.
• Lead continuous improvement for the CSV program and support regulatory inspections.

Connaissances

Technical writing

Regulatory compliance knowledge

Formation

Bachelor's Degree

Description du poste

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

As a Senior Quality Specialist – Computer Systems Validation, you will perform a variety of tasks related to auditing computer system validation as well as other documentation within the Systems Audits team as part of the Quality Assurance team.

Scope Of Responsibility

The scope of this position within the Systems Audit team as part of the Quality Assurance department includes impact on a range of important customer, operational, project or service activities with various teams. You will guide and influence peers or management regarding technical issues and challenges.

Essential Job Functions:

• Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
• Review validation documentation – such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures).
• Collaborate with global, cross-functional teams to accomplish company objectives and team goals including but not limited to on-time completion of system go-lives and enhancements.
• Manage continuous improvement efforts for the computerized systems validation program.
• Provide support for GxP regulatory inspections as needed, including acting as subject matter expert for Quality GxP computer validation topics.
• Provide Computer Validation tester/reviewer training as needed.
• Ensure archival of validation documentation – both paper and electronic.
• Monitor industry, new/revised regulations around SDLC and CSV and guidance for impact to the organization related to computer system validation.
• Review and approve deviations / OOS records and CAPAs.
• Review and approve change control (GCC) and IT Change Control records.
• Provide guidance and/or training for Quality Specialists.

Who You Are

Minimum Qualifications:

• Bachelor’s Degree in any discipline
• 6+ years' experience in validation, QA validation, validation tester, etc. within a pharmaceutical, life sciences or biotechnology environment.

Preferred Qualifications:

• Excellent technical writing skills and ability to document all work in an accurate and timely manner.
• Proficient knowledge of FDA and EU computer systems validation and associated regulations (cGMP, GLP, ICH, GAMP, DI, Part11)
• Acts ethicallyand ensures quality of own work and that of others.
• Collaborates with various teams to identify and implement improvements.
• Apply technology to drive digitalization, improve quality and increase customer value.
• Works with agility and drives and implements changes on local and global scales.

Pay Range for this position - $80,600 - $121,000

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!