Compliance Specialist

Planet Pharma Group; Westborough (MA); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Planet Pharma is seeking a Compliance Specialist CMC, Quality Assurance in Massachusetts to perform QA tasks supporting GMP and non-GMP manufacturing and regulatory submissions. The role emphasizes data integrity, quality, and compliance across QA areas.

You will review development studies for submissions, communicate QA results, and collaborate with cross-functional teams to ensure quality records are accurate and well documented.

Competenze

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP-regulated industry, or 1–2 years with a Master.
• In lieu of a Life Sciences degree, 6+ years of industry QA experience with high technical aptitude.
• Proficiency in MS Office (Excel and PowerPoint).

Mansioni

• QA review of development studies for regulatory submissions to ensure compliance.
• Communicate QA review results and reporting to stakeholders.
• Collaborate with cross-functional teams on quality events and records.

Conoscenze

MS Office

Formazione

Bachelor's degree in Life Sciences, Engineering, or Chemistry

Master's degree

Descrizione del lavoro

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 company 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.