The Opportunity: As an Associate II, you will work in a fast-paced, digital-first environment, utilizing cutting-edge analytical methods and automation systems. This hands-on role offers exposure to a wide range of advanced instrumentation and provides opportunities to contribute to process improvements and cross-functional quality initiatives.
Key Responsibilities:
- Conduct release and stability testing for drug substances and final drug products.
- Operate HPLC, UPLC, UV plate readers, and specialized chemical analysis equipment.
- Ensure full data integrity by documenting results within a Laboratory Information Management System (LIMS).
- Participate in OOS/OOT investigations and assist in implementing corrective actions (CAPAs).
- Collaborate on the revision of SOPs and technical reports to drive continuous improvement.
- Maintain a safe, 5S-compliant laboratory environment.
- Education: BA/BS in Chemistry (preferred) or a relevant scientific discipline.
- Experience: At least two years of experience in a Quality Control laboratory within a pharmaceutical company.
- Technical Skills: Proficiency in cGMP requirements, FDA/ICH regulations, and the operation of complex analytical instruments.
- Digital Mindset: An aptitude for learning new digital platforms and a commitment to utilizing technology to maximize accuracy and efficiency.
Apply now to join a team that values rapid learning and digital innovation to impact global health!
FOR MORE IMMEDIATE CONSIDERATION, email a current resume to iris.levy@randstadusa.com
salary: $48 - $48.61 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors
Responsibilities
Core Responsibilities: Associate II, Quality Control Chemistry
In this highly technical role, you will ensure the integrity of therapeutics through compliant analytical testing. Your primary duties include:
- Analytical Testing: Perform in-process, release, and stability testing for raw materials, intermediates, drug substances, and final products in a cGMP environment.
- Instrument Operation: Operate advanced analytical instrumentation, including HPLC, UPLC, UV plate readers, Dynamic Light Scattering, Karl Fischer (KF), and osmolality analyzers.
- Compliance & Documentation: Execute testing according to FDA/ICH regulations and internal SOPs, accurately documenting results in LIMS or Assay Performance Worksheets following Good Documentation Practices (GDP).
- Quality Investigations: Contribute to deviation investigations, including Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results, while assisting with CAPAs.
- Laboratory Support: Manage reagent preparation, equipment maintenance, sample management, and inventory of critical laboratory supplies.
- Continuous Improvement: Review, write, and revise SOPs and protocols to enhance operational excellence and support special projects or method troubleshooting.
- Safety & Integrity: Maintain a safe laboratory environment and ensure full data integrity across all quality systems.
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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.
