This role is ideal for a highly organized and detail-oriented entry-level scientific professional who thrives in a Quality Control GMP laboratory environment.
As a Stability Associate II, you'll be the hands-on backbone of the QC stability program, focusing heavily on the logistical management and physical handling of critical drug product and drug substance samples. Your daily duties will primarily involve aliquoting large product samples into smaller, usable portions for various teams, performing routine stability sample pulls, managing inventory, and coordinating shipments to external testing laboratories.
Success in this position requires a strong commitment to cGMP compliance, proficiency with LIMS and electronic databases, and the ability to maintain meticulous documentation while supporting cross-functional collaboration and continuous improvement initiatives. Weekend and holiday support may be required.
location: Norwood, Massachusetts
job type: Contract
salary: $40 - 46 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Performing day-to-day routine stability program operations, such as stability sample pulls, sample aliquoting, sample submissions to testing labs, and shipment preparations for external labs
- Creates, reviews and revises stability protocols and reports.Assists with and supports reporting of stability testing results both externally and cross-functionally.
- Assists with and performs stability set down and stability pull activities to include, but not limited to labeling, verifying sample quantities and updating in LIMS and/or appropriate logs/inventory sheets.
- Assists with creating stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur and are distributed to the test labs as scheduled and within appropriate timelines.
- Supports routine stability sample inventory management, assessment and sample disposal activities.
- Performs the required functions for stability studies in LIMS, including data entry review and approval.
- Supports and executes on stability sample shipments to external labs
- Requests and retrieves stability testing data/reports from external vendors and shared folders and updates in-house stability binders and databases accordingly.
- Assists with and executes on ordering of laboratory consumables and supplies, managing/stocking QC lab supplies
- Assists with continuous improvement initiatives for the GMP stability programs between US and Global.
qualifications:
Required:
- BA/BS in a relevant scientific discipline with 0-2 years in a GMP QC laboratory setting
- Prior experience with cGMPs, general laboratory safety and pipetting
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS)
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
skills: Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP), Quality Control (QC), International Council for Harmonization (ICH), Quality Management Systems (QMS)
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.
