Lab Operations Specialist

Regulatory Lab Specialist for a 6‑month+ contract role based in North Billerica, MA. The position supports initiatives in a highly regulated bioscience environment, ensuring compliance with FDA regulations and ISO standards. Contract rate: $38–$40 per hour; work hours: 8 am to 5 pm. Responsibilities Work with R&D, Manufacturing, Product Support, and Marketing to improve product quality to meet current cGMP standards. Ensure compliance with 21 CFR Part 820 and ISO 13485 standards, focusing on documentation control. Identify and implement process improvements. Maintain accurate records and handle confidential information appropriately. Work independently and support team objectives with minimal supervision. Requirements Bachelor of Science Degree in Engineering, Life Sciences, or equivalent experience; 5+ years in manufacturing, laboratory, or quality positions supporting FDA‑regulated products. Proven knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices. Understanding of software programs (Microsoft Word, Excel, PowerPoint) required to document existing and new documentation. Previous experience with ERP systems and electronic document management systems is preferred. Detail‑oriented, able to work independently and collaboratively in cross‑functional teams. Outstanding verbal and written communication, interpersonal, problem‑solving, and customer service skills. Self‑starter, able to prioritize and handle multiple tasks, meet strict deadlines, and handle highly confidential messages and correspondence. Qualifications Experience level: Experienced Minimum 5 years of experience Education: Bachelor’s degree Skills MS Office SOPs FDA Regulations Documentation Control ERP Systems Benefits Randstad offers a comprehensive benefits package which may include medical, prescription, dental, vision, AD&D, life insurance, short‑term disability, and a 401(k) plan, subject to eligibility. Equal Opportunity Employer We welcome people of all abilities and provide reasonable accommodations. Randstad is an 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 are not factors in hiring decisions. 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. Posting is open for thirty (30) days. #J-18808-Ljbffr