QC Analyst II​/III

Overview

Be Seen and Heard at Eye Point
At EyePoint, 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, with a commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. EyePoint delivers innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases.

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

Individual Responsibilities

• Perform routine laboratory housekeeping to ensure the maintenance and compliance of the 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 (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 FDA regulations.
• Identify laboratory anomalies and/or discrepancies and escalate to management in a timely manner, coordinating 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 planning to meet schedules, timelines, and deadlines as per procedures and 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.
• Knowledge of cGMPs and related compliance regulations and guidance (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 (HPLC). Empower Software experience is a plus.
• Ability to perform the detailed job requirements competently, safely, and proficiently.
• Team player with integrity and commitment to quality of company products, services, and staff.
• Self-starter with good interpersonal skills capable of effectively interacting with all departments and suppliers.
• Excellent organizational, verbal communication, technical documentation and computer skills.
• Routinely exercises sound judgment, reasoning and problem solving.
• Ability to complete assigned responsibilities under minimal supervision and keep management informed of work status.
• Flexible and able to respond quickly to shifting priorities to meet deadlines.
• Position may involve use of reagents and other chemical compounds that are considered hazardous.
• Ability to communicate and work independently with scientific/technical personnel in internal and external settings.

Level Of Education Required

BS/BA or higher degree or an equivalent combination of education and experience in related field of pharmaceutical or biopharmaceutical industry.

Preferred Field of Study
:
Chemistry/Biochemistry or related field.

Experience

QC Analyst II: 3-5 years of demonstrated practical Quality Control experience in GMP-regulated laboratory.

QC Analyst III: 6-8 years of demonstrated practical Quality Control experience in GMP-regulated laboratory.

With the exciting energy of a winning culture and an exhilarating pace, EyePoint is a ophthalmology company committed to improving the lives of patients with serious retinal diseases by developing and commercializing innovative therapeutics. The values influence…