EyePoint · 14 hours ago
QC Analyst II/III
Watertown, MA
Full-time
Onsite
Mid, Senior Level
$77K/yr - $119K/yr
3+ years expEyePoint is an ophthalmology company committed to improving the lives of patients with serious retinal diseases by developing and commercializing innovative therapeutics. The QC Analyst II/III will be responsible for all aspects of quality control related to clinical trial materials and commercial products, ensuring compliance with GxP regulations and internal procedures.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
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 field of pharmaceutical or biopharmaceutical industry
Preferred
Preferred Field of Study: Chemistry/Biochemistry or related field
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
Benefits
Robust total rewards
Commitment to developing and commercializing innovative therapeutics
Company
EyePoint
EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.
51-200 employees
H1B Sponsorship
EyePoint has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$803.8MKey Investors
Silicon Valley BankOcumension TherapeuticsEssex Woodlands Healthcare Partners
2025-10-14Post Ipo Equity· $150M
2023-12-05Post Ipo Equity· $215.9M
2022-03-09Post Ipo Debt· $45M
Leadership Team
Paul Ashton
President, Chief Executive Officer and a Director
D
Diane Shay
Vice President of Quality
Recent News
2025-12-17
2025-12-16
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-11-21
Company data provided by crunchbase