Quality Control Analyst I/II

EyePoint Pharmaceuticals, Inc.•Northbridge, MA

1d•Onsite

About The Position

Be Seen and Heard at EyePoint 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, 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 EyePoint 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 Northbridge, MA. The individual will ensure that all products are tested, in accordance with all applicable GxP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines), as well as internal company procedures. This position is located at our Northbridge, MA site.

Requirements

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 field of pharmaceutical or biopharmaceutical industry
QC Analyst I: 1-3 years of demonstrated practical Quality Control experience in GMP regulated laboratory.
QC Analyst II: 3-5 years of demonstrated practical Quality Control experience in GMP regulated laboratory.

Nice To Haves

Empower Software experience is a plus.
Preferred Field of Study: Chemistry/Biochemistry or related field.

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 escalate to management in a timely manner. Work with laborary 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.