This dynamic contract opportunity for an Associate II, Quality Control Chemistry is ideal for a scientifically disciplined individual eager to launch or advance their career in pharmaceutical Quality Control.
The role involves hands-on analytical testing of critical pharmaceutical materials (raw materials, drug substance, intermediates, and drug products) using advanced equipment such as HPLC, UPLC, UV, and Dynamic Light Scattering (DLS), ensuring strict adherence to cGMP, FDA, and ICH regulatory requirements. The successful candidate will be a meticulous organizer, responsible for detailed documentation, laboratory support, compliance with data integrity and GDP, and contributing to lab investigations and SOP review. If you have a foundational degree in a scientific field and 0-2 years of QC lab experience, this is an excellent chance to gain specialized skills within a pharmaceutical environment in a high-impact, compliance-focused chemistry setting.
location: Norwood, Massachusetts
job type: Contract
salary: $35 - 45 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Work on in-process, release and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH and other regulatory requirements.
- Routinely use analytical equipment including, but not limited to HPLC, UPLC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
- Follow current test methods and/or protocols to perform analytical testing.
- Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review
- Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.
- May assist with troubleshooting of assay methods and equipment.
- Involved in lab investigations, OOS, OOT, OOE and deviation investigations.
- May Implement CAPAs and perform effectiveness check.
- Complete on job training activities
- Help with inventory management of reference standards, reagents, supplies for testing
- Review/write/revise SOPs, protocols and reports
- Establish and maintain a safe laboratory working environment
- Supports special projects as assigned
qualifications:
Education & Qualifications
Required:
- BA/BS in relevant scientific discipline
- 0-2 years in a quality control laboratory performing HPLC
- Previous experience working at a pharmaceutical company
skills: Quality control, HPLC, SOP, CAPA, GMP (Good Manufacturing Practice)
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.
