Compliance Specialist

Spectraforce Technologies, Inc.; Westborough (MA); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Spectraforce Technologies, Inc. is seeking a Compliance Specialist to support QA activities for GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM in Westborough, MA. This 6-month contract emphasizes data integrity, quality, and compliance across QA areas.

Required qualifications include a BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years of QA GMP experience, or 1–2 years with a Master’s degree, and strong MS Office skills (Excel, PowerPoint).

Competenze

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA experience in GMP-regulated industry, or 1–2 years with Masters degree.
• Working fluency in the Microsoft Office productivity suite (Excel, PowerPoint).

Mansioni

• Performs QA review of development studies for regulatory submissions, including draft batch records and analytical test records.
• Ensures developmental studies comply with approved protocols and regulatory guidelines.
• Identifies and reports documentation errors and deviations from protocols and specifications.
• Communicates QA review, audit results and reporting to stakeholders.
• Collaborates with cross-functional teams to address quality events with clear, evidence-backed records.

Conoscenze

MS Office

Excel

PowerPoint

QA Principles

Formazione

BS/BA in Life Sciences, Engineering, or Chemistry

Masters degree

Descrizione del lavoro

Job Title: Compliance Specialist

Location: Westborough, MA, 01581

Duration: 06 months

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 the Client to help ensure high quality standards and value delivery for our patients.

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.

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.