Regulatory Lab Specialist for a 6-month+ contract role based in the Billerica, MA area. This role will support ongoing initiatives in a highly regulated bioscience environment and play a key role in ensuring compliance with FDA regulations and ISO standards.
The right person will have a passion for science and especially the details, being responsible for maintaining documentation control, tracking quality metrics, and supporting both internal and external audit processes.
If this role sounds like you, Apply now for immediate consideration!
location: North Billerica, Massachusetts
job type: Contract
salary: $38 - 40 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Work with R and 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.
- Bachelor of Science Degree in Engineering or Life Sciences or equivalent experience (5-year's experience in manufacturing, laboratory or quality position supporting FDA regulated products).
- Proven knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices
- Understanding of various software programs (i.e., Microsoft Word, Excel, PowerPoint) required to document existing and new documentation.
- Previous experience with ERP systems, electronic document management systems preferred
- Detail-oriented with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
- Must possess outstanding communication (verbal and written), interpersonal, problem solving
and customer service skills. - Must be self-starter, able to prioritize and handle multiple tasks and ability to meet strict
deadlines and handle highly confidential messages and correspondence.
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors
skills:
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.
