This is a self-guided, 5.5-month contract role for a Compliance Specialist CMC, Quality Assurance, perfect for a dedicated professional with a background in reviewing regulated data. You will be central to the team, performing the critical QA review of executed development study documentation (like batch and analytical records) that is directly intended for government regulatory submissions. This role offers a flexible, collaborative, and results-focused environment within a large quality department (35-40 people). If you are a self-starter with effective communication skills and a meticulous approach to accuracy and efficiency, you will thrive by managing your own workflow and providing essential quality oversight to the study teams.
location: Westborough, Massachusetts
job type: Contract
salary: $35 - 46 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- 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.
qualifications:
Required:
- BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related experience, OR 1-2 years of experience with a Masters degree
- 2-3 years of prior GMP/GLP/GCP experience with QA/QC data review, specifically demonstrating experience reviewing various types of data within these regulated environments.
- Effective Communication skills for clear interaction across the team and with cross-functional departments.
- A proven ability to be a Self-Starter, demonstrating collaboration and a team-player attitude, capable of efficiently managing a high-volume workload.
- An analytical background.
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice), Batch Record
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
