Redbock - an NES Fircroft company
Compliance Specialist (Rensselaer County)
Redbock - an NES Fircroft company, Rensselaer, New York, United States
Compliance Specialist
External Manufacturing (On-Site, New York)
12-Month Contract | Potential for Extension | Full-Time, On-Site A large, rapidly growing pharmaceutical company in New York is seeking an experienced
Compliance Specialist
to join the
External Manufacturing Compliance team
for a 12-month project, with strong potential for extension. This role will support the companys expanding external manufacturing network and ensure all activities performed by contract manufacturing organizations (CMOs) meet internal and regulatory quality standards. The ideal candidate will have hands-on experience managing quality system elements, collaborating with external partners, and driving continuous improvement within a cGMP environment. Responsibilities Own and manage
Change Controls, Deviations, CAPAs, and SCARs
within the companys Quality Management System (QMS) for both clinical and commercial manufacturing. Ensure all externally manufactured materials comply with company quality standards and regulatory expectations. Partner cross-functionally with
External Manufacturing Operations ,
Quality Assurance , and other stakeholders to maintain alignment on priorities and timelines. Facilitate meetings to track progress, review updates, and manage open quality records. Contribute to the improvement and revision of
Standard Operating Procedures (SOPs)
and departmental processes. Support or lead
audits and compliance reviews
for external manufacturing partners. Qualifications Bachelors degree in a scientific or engineering discipline (required). Minimum
5 years of experience
in the
pharmaceutical or biotechnology
industry. Demonstrated experience with
Change Control ,
CAPA , and
Deviation management . Strong knowledge of
cGMP
and regulatory compliance requirements. Proven ability to work cross-functionally and communicate effectively with CMOs or external manufacturing partners. Excellent
technical writing
and
documentation
skills. Experience authoring or reviewing
SOPs
and supporting audits preferred.
External Manufacturing (On-Site, New York)
12-Month Contract | Potential for Extension | Full-Time, On-Site A large, rapidly growing pharmaceutical company in New York is seeking an experienced
Compliance Specialist
to join the
External Manufacturing Compliance team
for a 12-month project, with strong potential for extension. This role will support the companys expanding external manufacturing network and ensure all activities performed by contract manufacturing organizations (CMOs) meet internal and regulatory quality standards. The ideal candidate will have hands-on experience managing quality system elements, collaborating with external partners, and driving continuous improvement within a cGMP environment. Responsibilities Own and manage
Change Controls, Deviations, CAPAs, and SCARs
within the companys Quality Management System (QMS) for both clinical and commercial manufacturing. Ensure all externally manufactured materials comply with company quality standards and regulatory expectations. Partner cross-functionally with
External Manufacturing Operations ,
Quality Assurance , and other stakeholders to maintain alignment on priorities and timelines. Facilitate meetings to track progress, review updates, and manage open quality records. Contribute to the improvement and revision of
Standard Operating Procedures (SOPs)
and departmental processes. Support or lead
audits and compliance reviews
for external manufacturing partners. Qualifications Bachelors degree in a scientific or engineering discipline (required). Minimum
5 years of experience
in the
pharmaceutical or biotechnology
industry. Demonstrated experience with
Change Control ,
CAPA , and
Deviation management . Strong knowledge of
cGMP
and regulatory compliance requirements. Proven ability to work cross-functionally and communicate effectively with CMOs or external manufacturing partners. Excellent
technical writing
and
documentation
skills. Experience authoring or reviewing
SOPs
and supporting audits preferred.