Quality Control Analyst jobs in Waltham, MA

Quality Control Analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Conducts and validates various biological and chemical quality control (QC) assays. Being a Quality Control Analyst compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations. May be responsible for establishing specifications for conducting assays and writing standard operating procedures. Additionally, Quality Control Analyst typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Quality Control Analyst work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Control Analyst typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Quality Control Analyst II
  • EyePoint Pharmaceuticals, Inc.
  • Watertown, MA FULL_TIME
  • Overview

    Be Seen and Heard at EyePoint Pharmaceuticals

    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 success for:

     

    • preventing blindness through vision-saving medications
    • delivering best-in-class proprietary pharmaceutical technologies
    • transforming ocular drug delivery

     

    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 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 with potential to relocate to the Northbridge, MA QC laboratory when appropriate. 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.

     

    Responsibilities

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

     

    Individual responsibilities

     

    • Perform QC analytical testing for drug products and raw materials (release and stability samples). Evaluates and reduces QC analytical testing data in a timely manner.
    • Perform technical review of QC testing data and external testing data.
    • Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.
    • 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.
    • Assist in QC sample management for internal and external testing samples.
    • Prepare reagents and standards per procedure ensuring proper handling, storage and disposal of hazardous materials.
    • Provide support for analytical data tracking and trending.
    • Work under minimal supervision to 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 laboratory personnel and management to address issues.
    • Provide support for investigations regarding deviations, out-of-trend (OOT)/out-of-specification (OOS) results
    • Provide analytical testing support for development protocols and reports as appropriate
    • Assist in development of training programs for QC analysts.
    • 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.
    • Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.

    Qualifications

    Primary skills and knowledge required include, but are not limited to the following:

     

    • 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.
    • Hands on experience with analytical chemistry instruments and techniques: High-Performance Liquid Chromatography (HPLC) required. (Empower Software experience is a plus). Experience with basic laboratory equipment such as balances, automatic pipettes, pH meters
    • 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.

     

    Level of Education Required:

    Chemistry/Biochemistry or related field.

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

     

    Number of Years of Experience in the Function and in the Industry:

     

    3-6 years of demonstrated practical Quality Control experience in GMP regulated laboratory.

     

    Envision Your Future

     

    With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

     

    The collective power of our values influences everything we do, and everything we do for you.

    • Success begins with our People
    • Patients First
    • Integrity
    • Results-Driven
    • Innovation
    • Team Focus
    • Diversity & Inclusion

    EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

     

    #LI-Onsite

     

     

  • 19 Days Ago

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Quality Control Analyst I
  • EyePoint Pharmaceuticals, Inc.
  • Watertown, MA FULL_TIME
  • Overview Be Seen and Heard at EyePoint Pharmaceuticals At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels o...
  • 19 Days Ago

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Quality Control Analyst II
  • Vericel
  • Cambridge, MA FULL_TIME
  • Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join ...
  • Just Posted

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Quality Control Analyst
  • Synectics Inc
  • Devens, MA FULL_TIME
  • Job Description: The QC Analyst is responsible for supporting Quality Control analytical testing of Incoming Raw Materials. This includes in house testing and sending out samples to contract testing l...
  • 3 Days Ago

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Analyst II, Quality Control
  • Arranta Bio LLC
  • Watertown, MA FULL_TIME
  • JOB SUMMARY The Quality Control analyst will primarily be responsible for supporting early phase and commercial quality control activities. This highly motivated member of the Quality Unit will suppor...
  • 4 Days Ago

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Senior Analyst, Quality Control
  • Vor Bio
  • Cambridge, MA FULL_TIME
  • Who we are looking for: Vor Bio is seeking an experienced Quality Control Senior Analyst who will be responsible for executing activities related to establishment / release / testing of raw materials ...
  • 1 Month Ago

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0 Quality Control Analyst jobs found in Waltham, MA area

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QC Analyst II, Microbiology - (Noon-8pm shift)
  • Astellas Pharma
  • Westborough, MA
  • Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are d...
  • 3/28/2024 12:00:00 AM

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Quality - Quality Control Technician
  • HonorVet Technologies
  • Devens, MA
  • Job Description: Quality Control Technician 100% Onsite- Devens, MA Work Schedule: 1st shift hours, Monday - Friday 7AM ...
  • 3/28/2024 12:00:00 AM

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Quality Control Technician
  • Aequor Technologies LLC
  • Devens, MA
  • Job Description: Quality Control Technician 100% Onsite- Devens, MA Work Schedule: 1st shift hours, Monday - Friday 7AM ...
  • 3/28/2024 12:00:00 AM

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Quality Control Technician
  • Sunrise Systems Inc
  • Devens, MA
  • Job Title: Quality Control Technician Job ID: 24-01423 Location: Devens, MA, 01434 Duration: 12 Months contract on W2 10...
  • 3/28/2024 12:00:00 AM

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Quality Control Analyst
  • Pace Analytical Services, LLC
  • Waltham, MA
  • Quality Control Analyst ID 2024-4634 # of Openings 1 Job Location(s) US-MA-Waltham Category Science OVERVIEW This candid...
  • 3/27/2024 12:00:00 AM

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Quality Control Analyst II - NHPRR
  • UMass Med School
  • Worcester, MA
  • Quality Control Analyst II - NHPRR Minimum Salary US-MA-Worcester Job Location 2 days ago(3/24/2024 12:12 PM) Requisitio...
  • 3/27/2024 12:00:00 AM

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Quality Control Analyst II
  • PSG Global Solutions Careers
  • Northborough, MA
  • Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We'...
  • 3/27/2024 12:00:00 AM

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Quality Control Technician
  • Eurofins
  • Rowley, MA
  • Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytica...
  • 3/26/2024 12:00:00 AM

Waltham (/ˈwɔːlθæm/) is a city in Middlesex County, Massachusetts, United States, and was an early center for the labor movement as well as a major contributor to the American Industrial Revolution. The original home of the Boston Manufacturing Company, the city was a prototype for 19th century industrial city planning, spawning what became known as the Waltham-Lowell system of labor and production. The city is now a center for research and higher education, home to Brandeis University and Bentley University. The population was 60,636 at the census in 2010. Waltham is commonly referred to as W...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Control Analyst jobs
$61,644 to $84,642
Waltham, Massachusetts area prices
were up 2.5% from a year ago

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