QC Analyst II​/III

Overview

Be Seen and Heard at Eye Point

At Eye Point , leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our:

• focus on science and innovation, we aim to offer a lifetime of clearer vision
• commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases
• Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases.

We See You.

Your wellbeing

Your professional worth

Your future at Eye Point

EyePoint offers robust total rewards in a
science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career.There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This person will report directly to the quality control supervisor/manager and will be responsible for all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides production support for analytical quality control testing of pharmaceutical raw materials and drug products.

The individual will work in the QC laboratory located in Watertown, MA. The individual will ensure that all products are tested, in accordance with all applicable GxP regulations and guidelines (e.g. 21

CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines), as well as internal company procedures.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

• Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.
• Prepare reagents and standards, and analytical testing solutions per procedure ensuring proper handling, storage and disposal of hazardous materials.
• Perform reagent and consumable inventory management for the QC lab.
• Perform QC sample management for internal and external testing. samples (QC sample receiving, shipping, and reconciliation)
• Perform QC analytical testing for drug products and raw materials (release and stability samples). Evaluate and reduce QC analytical testing data in a timely manner.
• Perform technical review of QC testing data and external testing data.
• Provide support for inspection and testing of incoming raw materials.
• Provide support to analytical development for QC analytical method validation and method transfer.
• Assist in authoring and reviewing standard operating procedures , test methods, and work instructions related to QC activities.
• Provide support for analytical data tracking and trending.
• Ensure all work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
• Identify laboratory anomalies and/or discrepancies then elevate to management in a timely manner. Work with laboratory personnel and management to address issues.
• Provide support for investigations regarding deviations, out-of-trend (OOT)/out-of-specification (OOS) results
• Perform workload to meet schedules, timelines, deadlines as per procedure’s and/or department requirements.
• Support internal and external audits and regulatory inspections, as required.

Primary skills and knowledge required include, but are not limited to the following:

• Experience in analysis of pharmaceutical products by USP/EP methods required.
• Knowledge of cGMPs and related compliance regulations and guidance’s is required (e.g. Title 21 CFR Parts 11, 210/211, 820,) USP/EP / ICH Guidelines.
• Experience with basic laboratory housekeeping (glassware cleaning, laboratory organization and upkeep)
• Experience with basic laboratory equipment such as balances, automatic pipettes, pH meters, water baths. Experience with analytical chemistry instruments and techniques:
  High-Performance Liquid Chromatography (HPLC) . Empower Software experience is a plus.
• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently
• Must be a team player with…