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 everything we do and everything we do for you.

Transformational Innovation We exist to change our patients  lives through the power of sight. We are forward-looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high…