CMC Stability Associate

job summary:
The CMC Stability team is seeking a diligent contract Associate who will help support data verification (DV) for CMC Stability.

You will independently verify information and data points against designated source records, including LIMS data and reports, for use in stability documents and regulatory filings. Your routine workflow will involve processing DV requests from CMC Stability and our DV systems on a daily and weekly basis.

location: Norwood, Massachusetts
job type: Contract
salary: $28 - 32 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Complete required training and perform data verification in accordance with internal SOPs, guidance, and good documentation practices.
• Compare stability tables and document data with source records, checking values, units, batch identifiers, time points, and source references.
• Receive and prioritize daily DV requests with CMC Stability based on agreed deadlines.
• Process requests accurately and on time; promptly escalate missing information, unresolved discrepancies, or deadline risks to CMC Stability.
• Document discrepancies, work with document authors to resolve them, and recheck corrections before closing requests.
• Maintain complete, traceable verification records and request status in designated systems.
• Provide feedback to CMC Stability regarding DV procedures and recurring issues.

 
qualifications:
Required

• Education: Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline.
• Experience: No previous experience required.

Preferred

• Previous industry experience preferred.
• Superior attention to detail.
• Experience in a cGMP environment preferred.
• Experience with LIMS systems preferred.
• Experience with document control systems preferred.
• Proficiency with Microsoft Excel and Word, with clear written communication and organizational skills.
• Self-motivated and able to work independently; equally able to work as a member of a team.

 
skills: Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP), Chemistry Manufacturing and Controls (CMC)


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 View email address on 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.