Research Associate II, Quality Control

Ocular Therapeutix•Bedford, MA

3d•$85,000 - $91,000

About The Position

Ocular Therapeutix is seeking a Research Associate II to join its Quality Control team and perform routine quality control testing in support of critical late-stage program activities. The role also supports analytical method development and validation for the Analytical Development group, along with project support, data review, laboratory supply ordering, and general laboratory upkeep. The position performs QC analytical chemistry testing using laboratory equipment and instrumentation, authors technical reports, helps maintain instrument calibration and qualification, troubleshoots instrumentation issues, and coordinates testing schedules and outsourced testing. It also supports quality-system activities, including CAPAs, change controls, investigations, and deviations, working with Quality Assurance toward timely closure. The role requires adherence to cGMPs and Good Documentation Practices, including maintaining contemporaneous records and completing logbooks and forms. The salary range is $85,000–$91,000 USD. The position requires working in both office and chemical laboratory environments.

Requirements

Bachelor’s degree in chemistry or a related field.
At least 2 years of relevant work experience; experience in a quality control function is ideal.
At least 1 year of HPLC/UPLC work experience.
At least 1 year of experience in a GMP environment.
Knowledge of safe laboratory practices.
Strong verbal and written communication skills.
Ability to work in both office and chemical laboratory environments.

Nice To Haves

Knowledge of CFR 210, CFR 211, USP, and FDA/ICH guidance.
Experience with USP Apparatus IV dissolution equipment.
Relevant work experience in a quality control function.

Responsibilities

Support QC analytical chemistry testing using laboratory equipment and instrumentation, including HPLC, UPLC, GC, KF, and dissolution equipment.
Author technical reports as required.
Ensure instrument calibration and qualification are current and performed on schedule.
Troubleshoot instrumentation issues and coordinate repairs with vendors as necessary.
Coordinate with the supervisor to schedule testing of reagents and product samples.
Participate in data review activities.
Participate in analytical method development and validation activities.
Coordinate external outsourcing of testing.
Support CAPAs, change controls, investigations, and deviations, and work toward their timely closure with Quality Assurance.
Follow Good Documentation Practices, including maintaining contemporaneous records and completing logbooks and forms.
Adhere to cGMPs at all times.
Order laboratory supplies and support project work and general laboratory upkeep.