associate ii, quality control chemistry - 2nd shift, wed-sat

$72,800 - $87,027/Yr

Randstad - Norwood, MA

Full-time - Entry Level

Norwood, MA

Administrative and Support Services

About the position

The Associate II, Quality Control Chemistry position is a contract role focused on performing cGMP QC Chemistry testing for various samples including release, stability, and in-process samples. The role involves routine analytical chemistry testing and supporting special projects, while ensuring compliance with regulatory and internal requirements.

Responsibilities

• Perform cGMP QC Chemistry testing for QC Chemistry, release, stability, and in-process samples.
• Conduct routine analytical chemistry testing including HPLC, UPLC, GC, UV, Particle Analysis, Dynamic Light Scattering, and KF.
• Support special projects as assigned.
• Assist with troubleshooting assay methods and equipment.
• Perform data entry and support trending activities.
• Conduct general laboratory support activities including reagent preparation, sample management, equipment maintenance, and lab housekeeping.
• Support authoring of SOPs, protocols, and reports.
• Enter sample results in LIMS (LabVantage) and execute Electronic Assay Forms in LIMS.
• Perform HPLC (AEX) and NaOH plate reader based assays in support of manufacturing process stat testing as needed.
• Support the stability program.
• Assist more junior staff with data review, training, and troubleshooting.
• Manage and stock QC lab supplies.
• Write and revise SOPs, protocols, and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as investigations, deviations, change controls, and CAPAs.
• Establish and maintain a safe laboratory working environment.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including SOPs and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and requalification cadence.
• Perform additional duties as assigned.

Requirements

• Bachelor's degree in a relevant scientific discipline.
• 2 years of laboratory experience.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations.
• A desire to make an impact as part of a high-growth, transformational company.

Nice-to-haves

• Experience with quality control processes.
• Familiarity with CAPA and GMP practices.

Benefits

• Health insurance coverage.
• Incentive and recognition program.
• 401K contribution.