GMP Quality Systems Specialist - Docs, CAPAs & Audits

BioSpace; East Norriton Township (Montgomery County); On-site; USD 65,000 - 87,500; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Flexible time off

Tuition reimbursement

Job summary

A leading biomanufacturing firm in East Norriton, PA, seeks a Quality Systems Specialist to develop and maintain a compliant GMP quality management program. Responsibilities include administering quality systems, managing controlled documents, and supporting internal and client audits. Ideal candidates will possess a relevant B.S. degree, quality experience, and proficiency in Microsoft 365. Compensation for this role ranges from $65,000 to $87,500 annually. Sponsorship for work authorization is not available.

Qualifications

• Demonstrated quality experience and effective collaboration.
• Knowledge of quality systems and software applications.
• Working knowledge of GxP Regulatory requirements.

Responsibilities

• Administer, maintain, and improve core quality systems.
• Review and manage controlled documents throughout their lifecycle.
• Support internal audits, client audits, and regulatory inspections.

Skills

Collaboration and influence

Quality systems knowledge

GxP Regulatory knowledge

Microsoft 365 proficiency

Education

B.S. in relevant discipline

Job description

A leading biomanufacturing firm in East Norriton, PA, seeks a Quality Systems Specialist to develop and maintain a compliant GMP quality management program. Responsibilities include administering quality systems, managing controlled documents, and supporting internal and client audits. Ideal candidates will possess a relevant B.S. degree, quality experience, and proficiency in Microsoft 365. Compensation for this role ranges from $65,000 to $87,500 annually. Sponsorship for work authorization is not available.