Senior Quality Control Chemist

3 days ago

Brooklyn, New York, United States Cresilon Inc Full time
Job Title: Senior Quality Control Chemist

Cresilon Inc is a leading biotechnology company that develops innovative hemostatic medical devices. We are seeking a highly skilled Senior Quality Control Chemist to join our team.

Job Summary

The Senior Quality Control Chemist will serve as our Subject Matter Expert (SME) and technical lead in Current Good Manufacturing Practices (cGMP) analytical chemistry. This role will involve working closely with FDA and other 3rd Party testing facilities to ensure compliance with applicable requirements.

Key Responsibilities
  • Ensure analytical methods are validated and analytical instrumentation are qualified to an extent commensurate with their risk and/or impact to product quality and patient safety.
  • Handle multiple project assignments of significant scope and technical complexity pertaining to analytical chemistry.
  • Establish methods for material identification, material impurity identification, and material composition and quality evaluation, as applicable.
  • Generate, review, and approve cGMP data pertaining to analytical chemistry in accordance with Good Documentation Practices (GDP).
  • Perform method transfer to/from R&D and to/from external laboratories.
  • Qualify analytical instrumentation in partnership with Quality Engineering.
  • Validate analytical methods in partnership with Quality Engineering and R&D.
  • Summarize analytical chemistry test data, including but not limited to maintaining lot histories and trend analysis for prospective non-conformance evaluation.
  • Establish cGMP documentation, including but not limited to procedures, protocols, and reports, pertaining to analytical chemistry.
  • Perform compliance activities, including but not limited to investigations and CAPAs, pertaining to analytical chemistry.
  • Review and approve all compliance activities involving analytical chemistry.
  • Execute routine analytical testing.
  • Mentor and train staff on cGMP analytical chemistry expectations.
  • Collaborate cross-functionally within Cresilon and with external parties to achieve outcomes.
  • Support laboratory operations by scheduling, planning, and executing applicable operations.
  • Identify, coordinate, and manage external testing as necessary.
Requirements
  • Bachelor's degree in chemistry, biochemistry, or related life-science discipline (Masters or Doctorate in analytical chemistry preferred).
  • 7+ years in medical device / pharmaceutical analytical chemistry quality control (10+ years preferred).
  • 4+ years of analytical chemistry method validation (7+ years preferred).
  • 4+ years of analytical chemistry method development (7+ years preferred).
  • Pharmaceutical and/or medical device analytical chemistry experience.
  • Experience with FDA submissions and FDA clearance on device/product.
  • Technical problem-solving using science and engineering principles.
  • Good Documentation Practices (GDP) and data integrity.
  • Analytical method validation per USP.
  • Analytical instrument qualification per USP.
  • Laboratory audits.
Benefits
  • Paid Vacation, Sick, & Holidays.
  • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage.
  • Company Paid Life and Short-Term Disability Coverage.
  • Work/Life Employee Assistance Program.
  • 401(k) & Roth Retirement Savings Plan with company match up to 5%.
  • Monthly MetroCard Reimbursement.

The salary range for this role is $100,000-$135,000.

Cresilon Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

  • Senior Quality Control Chemist

    2 weeks ago

    Brooklyn, New York, United States Cresilon Inc Full time

    About Cresilon IncCresilon Inc is a leading biotechnology company that develops innovative hemostatic medical devices utilizing proprietary hydrogel technology. Our mission is to revolutionize the standard for stopping traumatic and surgical bleeds in seconds without manual pressure.Job SummaryWe are seeking a highly skilled Senior Quality Control Chemist to...

  • Quality Control Specialist

    1 week ago

    Brooklyn, New York, United States Green Top Farms Full time

    Job Title: Quality Control ChefGreen Top Farms is seeking a highly skilled Quality Control Chef to join our team. As a Quality Control Chef, you will be responsible for ensuring the highest standards of food safety and quality in our high-volume kitchen.Key Responsibilities:Develop and implement food safety protocols to prevent contamination and ensure...

  • Quality Control Specialist

    5 days ago

    Brooklyn, New York, United States Green Top Farms Full time

    Job Title: Quality Control ChefAt Green Top Farms, we are seeking a highly skilled Quality Control Chef to join our team. As a key member of our kitchen staff, you will be responsible for ensuring the highest standards of food safety and quality in our high-volume food service and delivery operations.Responsibilities:Develop and implement food safety and...

  • Lead Quality Assurance Chemist

    4 weeks ago

    Brooklyn, New York, United States Cresilon, Inc. Full time

    Cresilon, Inc.: Expert in Analytical ChemistryCresilon, Inc., a pioneering biotechnology firm, is on the lookout for an Expert in Analytical Chemistry to enhance their dynamic team. The organization is dedicated to creating groundbreaking hemostatic medical devices utilizing plant-derived hydrogel technology aimed at swiftly controlling bleeding in both...

  • Infection Control Specialist and Quality Improvement Manager

    1 month ago

    Brooklyn, New York, United States The Brookdale Hospital Medical Center Full time

    Position Overview:The Infection Control Specialist is a dedicated healthcare professional possessing advanced expertise in Infection Prevention and Control. This role is pivotal in orchestrating strategic initiatives, ensuring adherence to regulatory standards, and managing the daily functions of the Infection Control Program. The specialist supervises...

  • Senior Nurse Leader

    2 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Lead a Team of Nurses in Senior CareSunrise Senior Living is seeking a Registered Nurse (RN) to lead a team of nurses in providing high-quality care to our residents. As a Nurse Manager, you will be responsible for overseeing the health and wellness of our residents, ensuring quality assurance and regulatory compliance, and promoting a culture of excellence...

  • Senior Nurse Leader

    2 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Senior Nurse Leader OpportunitySunrise Senior Living is seeking a dedicated and compassionate Registered Nurse to lead our clinical team in providing exceptional care to our residents.Responsibilities:Ensure quality assurance and regulatory compliance while promoting the highest degree of quality care and serviceOversee coordination of resident health and...

  • Senior Nurse Leader

    2 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Senior Nurse Leader OpportunitySunrise Senior Living is seeking a dedicated and compassionate Registered Nurse to lead our clinical team in providing exceptional care to our residents.Responsibilities:Ensure quality care and regulatory compliance while promoting a culture of excellenceOversee the coordination of resident health and wellness needs, including...

  • Senior Nurse Leader

    2 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Lead a Team of Nurses in Senior CareSunrise Senior Living is seeking a compassionate and experienced Registered Nurse to lead our team of nurses in providing high-quality care to our residents.Responsibilities:Ensure quality assurance and regulatory compliance while promoting the highest degree of quality care and serviceOversee coordination of resident...

  • Caregiver - Senior Living Assistant

    3 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    About the RoleWe are seeking a compassionate and dedicated Care Manager to join our team at Sunrise Senior Living. As a Care Manager, you will play a vital role in providing exceptional care and services to our residents, ensuring their physical, emotional, and social needs are met.Key ResponsibilitiesBuild meaningful relationships with residents and their...

  • Facilities Quality Control Manager

    1 month ago

    Brooklyn, New York, United States Green Top Farms Full time

    Facilities Quality Control Manager at Green Top FarmsGreen Top Farms is dedicated to fostering a sustainable and equitable food ecosystem by bridging the gap between consumers and local agriculture. The organization emphasizes the importance of providing nourishing and flavorful food to those in need, while advocating for social equity and minimizing...

  • Nursing Director

    3 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Nursing Director - Senior Care LeaderJob Summary:The Nursing Director - Senior Care Leader is a key member of the Sunrise Senior Living team, responsible for leading and managing the health and wellness of residents in our communities. This role requires a strong clinical background, excellent leadership skills, and a passion for delivering high-quality...

  • Senior Vice President of Quality Assurance

    1 month ago

    Brooklyn, New York, United States Little Flower Full time

    Job OverviewSalary Range: $110,000 - $130,000About Little Flower:Little Flower Children and Family Services of New York is a dedicated nonprofit organization committed to enhancing the lives of children, youth, and families throughout New York City and Long Island since 1929. Our team of over 500 professionals provides a variety of essential services,...

  • Senior Engagement Specialist

    4 weeks ago

    Brooklyn, New York, United States Signature Senior Living Full time

    Job Summary:We are seeking a highly motivated and compassionate Recreation Aide to join our team at Signature Senior Living. As a Recreation Aide, you will play a vital role in planning, implementing, and evaluating recreational, social, intellectual, emotional, and spiritual programs for our residents.Key Responsibilities:Assist in the planning and...

  • Senior Quality Assurance Manager

    3 weeks ago

    Brooklyn, New York, United States Universal Technologies Full time

    About the RoleUniversal Technologies is seeking a highly skilled Senior Quality Assurance Manager to lead our quality assurance efforts for a 100% remote position in the United States. As a Senior Quality Assurance Manager, you will be responsible for managing processes and personnel to conduct quality assurance of a Pension Administration system, which...

  • Quality Control Specialist

    1 month ago

    Brooklyn, New York, United States Center for Alternative Full time

    Job OverviewPosition Title: Quality Assurance SpecialistRole Summary:The Center for Alternative is on the lookout for a committed and skilled Quality Assurance Specialist to enhance our team. The selected individual will be instrumental in upholding the highest standards of service and adherence to various regulatory bodies.Key Responsibilities:Conduct...

  • Nursing Director RN

    1 day ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Job Title: Nursing Director RNAt Sunrise Senior Living, we are committed to providing high-quality care and services to our residents. We are seeking a skilled and compassionate Nursing Director RN to join our team.Job Summary:The Nursing Director RN will be responsible for leading and managing the nursing team, ensuring the health and wellness of our...

  • Nursing Director RN

    3 weeks ago

    Brooklyn, New York, United States Sunrise Senior Living Full time

    Nursing Director RN - Clinical LeaderJob Summary:Sunrise Senior Living is seeking a highly skilled and experienced Nursing Director RN - Clinical Leader to join our team. As a key member of our leadership team, you will be responsible for providing strategic leadership and direction to our nursing team, ensuring the delivery of high-quality care to our...

  • ESRI ArcMap Quality Assurance and Control Specialist

    3 weeks ago

    Brooklyn, New York, United States Amerit Consulting Full time

    Job SummaryAmerit Consulting is seeking a highly skilled ESRI ArcMap Quality Assurance and Control Specialist to join our team. As a key member of our GIS team, you will be responsible for ensuring the accuracy and quality of our mapping systems.Key ResponsibilitiesValidate the accuracy of legacy mapping data migrated to an Esri mapping system through...

  • Senior Office Coordinator

    1 month ago

    Brooklyn, New York, United States PruTech Solutions Inc Full time

    Position: Senior Office CoordinatorCompany: PruTech Solutions IncOverview:The Senior Office Coordinator plays a pivotal role in overseeing the various operations within the Administration and Quality Assurance departments. This position is essential for ensuring that all administrative functions are executed efficiently and effectively.Key...