Job opening
QC Specialist
Redbock - an NES Fircroft company
Filed under Pharmaceutical Manufacturing
Full job description
About the Company
A growing life sciences organization is seeking a QC Specialist to support analytical quality review activities across multiple development and commercial-stage programs. This position plays a key role in ensuring GMP compliance, supporting product release, reviewing analytical data, and partnering with external testing organizations.
About the Role
This is an opportunity to join a growing quality organization supporting a diverse product portfolio. The role offers broad exposure to analytical quality review, external partner management, product release activities, and cross-functional collaboration in a dynamic GMP environment.
Responsibilities
- Review and approve GMP analytical data, Certificates of Analysis, and supporting quality documentation.
- Support product release, stability, raw material, and in-process testing activities.
- Evaluate analytical results, trends, calculations, and laboratory records for accuracy and compliance.
- Investigate analytical deviations, OOS/OOT results, and other quality events.
- Collaborate with external laboratories and manufacturing partners to resolve technical and quality-related issues.
- Support cross-functional quality initiatives and maintain compliance with GMP requirements.
Qualifications
- BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- 4+ years of experience in pharmaceutical, biotechnology, or regulated GMP environments.
- Experience reviewing GMP analytical data and supporting batch release activities.
- Strong understanding of analytical chemistry, chromatography, data integrity, and quality systems.
- Experience working with external testing laboratories and contract partners.
- Familiarity with chromatography data systems such as Empower or OpenLab is preferred.
- Strong investigative, organizational, and communication skills.
Required Skills
- Small molecule pharmaceutical products.
- Analytical investigations, deviations, OOS/OOT events, and corrective actions.
- Clinical and commercial manufacturing support.