QC Analyst II​/III

Quality Control Analyst

Boston, MA

Salary: $77,250 - $119,480 per year

EyePoint is a science-based entrepreneurial culture that empowers curiosity and innovation.

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.

• 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 escalated 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.

• 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 integrity and concern for the quality of Company products, services and staff members.
• A self‑starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and suppliers.
• Must have excellent organizational, verbal communication, technical documentation and computer skills.
• Routinely exercises sound judgment, reasoning and problem solving.
• Capable of completing assigned responsibilities under minimal supervision and keeping 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 both internal and external setting.

BS/BA or higher degree or an equivalent combination of education and experience in related…