Compliance Specialist

Compliance Specialist

Job Title : Compliance Specialist

Location : Westborough, MA

Duration : 6 Months

Pay Rate : $46.66 / hr.

Start Date : Immediate

Job Description :

Responsibilities and Accountabilities :

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

• Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
• 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 test / data records, protocols, Standard Operating Procedures (SOPs), or specifications in a timely manner.
• Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Required Qualifications :

Preferred Qualifications :

This position is based in Westborough, MA and will require on-site work. Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.