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Associate II, Quality Control Chemistry

randstadlifesciences
locationNorwood, MA 02062, USA
PublishedPublished: 6/14/2022
Manufacturing
Full Time

Job Description

Job Descriptionjob summary:

This Associate II position in Quality Control Chemistry is critical to ensuring the integrity of the company's mRNA-based therapeutics through robust, compliant analytical testing. This individual will be part of the cGMP Quality Control organization, performing in-process, release, and stability testing. The role is highly technical and hands-on, offering exposure to cutting-edge analytical methods and digital systems, while supporting lab investigations, troubleshooting, and documentation in a fast-paced environment. The Associate II will contribute to the success of the QC lab by maintaining high standards in data integrity, operational excellence, and safety. It is a highly collaborative individual contributor role with opportunities to contribute to process improvements, special projects, and cross-functional quality initiatives.


location: Norwood, Massachusetts
job type: Contract
salary: $35 - 45 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

  • Conduct in-process, release, and stability testing for raw materials, intermediates, drug substances, and final drug products.
  • Execute testing according to cGMP requirements, FDA and ICH regulations, and internal SOPs.
  • Operate a wide range of analytical instruments including HPLC, UPLC, UV plate reader, Dynamic Light Scattering, Karl Fischer (KF), osmolality analyzers, and others.
  • Accurately document test results using Assay Performance Worksheets and/or Laboratory Information Management System (LIMS) following GDP principles.
  • Ensure full data integrity and adherence to QC laboratory compliance requirements.
  • Participate in general laboratory upkeep including reagent preparation, equipment maintenance, sample management, and 5S compliance.
  • Contribute to deviation investigations such as OOS, OOT, OOE, and assist in implementing CAPAs and conducting effectiveness checks.
  • Provide support for special projects as assigned, and assist in method/equipment troubleshooting when needed.
  • Review, write, and revise SOPs, protocols, and reports as part of continuous improvement.
  • Help manage inventory of reagents, reference standards, and critical laboratory supplies.
  • Participate in ongoing training to ensure current knowledge of procedures and best practices.
  • Promote and maintain a safe laboratory working environment.


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

#LI-RA1


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.

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