Compliance Specialist

Zenith LifeScience; Westborough (MA); Presencial; USD 65.000 - 75.000; Jornada completa

Descripción de la vacante

Zenith LifeScience LLC. in Westborough, MA is seeking a Compliance Specialist CMC to support QA activities for GMP-regulated manufacturing programs and regulatory submissions.

The role emphasizes data integrity, quality, and compliance across QA areas and collaboration with cross-functional teams to ensure high standards. The candidate will review development studies, manage QA communications, and work with stakeholders to document quality events and deviations in a regulated environment.

Formación

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP-regulated industry.
• MS degree may count for 1–2 years experience in lieu of Life Sciences degree.
• 6+ years in biotech/pharma QA acceptable in lieu of degree depending on experience.

Responsabilidades

• Performs QA review of development studies for regulatory submissions.
• Communicates QA review results and findings.
• Collaborates with cross-functional teams to document quality events and deviations.

Conocimientos

Data integrity

QA documentation

Educación

BS/BA in Life Sciences, Engineering, or Chemistry

Herramientas

Microsoft Office Suite (Excel, PowerPoint)

Descripción del empleo

Compliance Specialist CMC

Location: Westborough, MA 02181 (Onsite)

Duration: 6 Months

Job Description

The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Astellas to help ensure high quality standards and value delivery for our patients.

Compliance Specialist CMC

Location: Westborough, MA 02181 (Onsite)

Duration: 6 Months

Job Description

The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Astellas to help ensure high quality standards and value delivery for our patients.

Responsibilities And Accountabilities

Essential Duties and Responsibilities include, but are not limited to, the following:

• Performs QA review of executed development studies intended for regulatory submissions, included but not limited to draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards. Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner.
• Responsible for communicating QA review, audit results and reporting.
• Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Required Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
• Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred Qualifications

• Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and exercise sound Quality-by-Design principles.