Sr QA Specialist

1 week ago

Rensselaer, United States Regeneron Pharmaceuticals, Inc Full time

We are currently looking to fill a Sr QA Specialist position supporting our new fill finish facility. This position will be responsible to ensure that materials used in manufacturing are of the appropriate quality to ensure the production of drug products meeting or exceeding expectations.

In this role, a typical day may include the following:

Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution,

Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.

Train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization;

Provides consultation or advice in alignment with QA policies;

Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk

Review, edit, or approve Regeneron controlled documents

Review and approve investigations associated with raw materials, product, laboratory, facilities, or materials

Evaluates a variety of Supplier documentation for adequacy

Evaluates internal and external changes to determine acceptability

Prepares and reviews protocols and summary reports for the qualification of materials (raw materials, and drug product and medical device components)

Manages and tracks projects to ensure milestones are achieved while complying with established timelines

Supports the resolution of internal and external deviations, and Supplier Corrective Action Requests (SCARs) related to materials

This role may be for you if you:

Understanding of biologics manufacturing operations is preferred

Good organizational skills and attention to detail

Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

Ability to handle multiple assignments and changing priorities.

Ability to learn and utilize computerized systems for daily performance of tasks

Ability to prioritize, manage multiple tasks, and meet deadlines

Ability to stand for periods of time when performing tasks on the floor (Raw Materials).

Ability to work a varied schedule including off shift and weekends.

To be considered for this role you must hold a Bachelor’s degree in a scientific discipline or related field and the following minimum amounts of relevant experience for each level:

Senior Specialist – 6+ years

Principal Specialist – 8+ years


May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

  • QA Material Supplier Specialist

    1 week ago

    Rensselaer, United States Regeneron Pharmaceuticals Inc. Full time

    The QA Material Supplier Specialist assures that raw materials used in manufacturing are of the appropriate quality for the production of drug products. This position will manage individuals who accomplish project objectives by planning and evaluating project activities. They will support Quality Assurance project initiatives, Regulatory and Partner...

  • QA Microbiology Specialist

    3 weeks ago

    Rensselaer, United States Regeneron Pharmaceuticals Inc. Full time

    We are currently looking to fill a QA Microbiology Specialist (Drug Substance) position. This position is responsible for leading and being a team member for microbiologically based initiatives. Aspects of training, investigation activities, project implementation, data collection, and coaching will be used. Large percentage of time will be applied observing...

  • Associate QA Specialist

    3 weeks ago

    Rensselaer, United States Regeneron Pharmaceuticals, Inc Full time

    The Quality Assurance, Raw Materials department at Regeneron is adding to their team! The QA Specialist - Raw Materials, performs activities in support of disposition product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Shift Available:...

  • Manager, QA Microbiology

    3 weeks ago

    Rensselaer, United States Regeneron Pharmaceuticals Inc. Full time

    We are currently looking to fill a Manager, QA Microbiology position. This position is responsible for the contamination control strategy for API/drug substance manufacturing facilities, ensuring compliance with regulatory requirements and industry standards. **In this role, a typical day might include the following**: Resolve problems, identify trends and...

  • Associate Manager QA Validation

    2 months ago

    Rensselaer, United States Regeneron Pharmaceuticals, Inc Full time

    The QA Validation Fill Finish team is hiring an Associate Manager! As the Associate Manager QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards...

  • Associate Manager QA Validation

    4 weeks ago

    Rensselaer, United States Regeneron Pharmaceuticals, Inc Full time

    The QA Validation Fill Finish team is hiring an Associate Manager! As the Associate Manager QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards...

  • QA/Expeditor - North Greenbush Chili's

    4 weeks ago

    Rensselaer, United States Chili's Grill & Bar Full time

    QA/Expeditor - North Greenbush Chili's 101 Van Rensselaer Square Rensselaer, NY 12144 Min: $15.00 Hourly | Max: $17.50 Hourly Role Overview Our Quality Assurance Specialists ensure each Guest receives perfectly prepared, high-quality food. They provide dependable, fast service that is absolutely Chili's! If you take pride in great team work, then we want to...

  • QA/Expeditor - North Greenbush Chili's

    4 weeks ago

    Rensselaer, United States Chili's Grill & Bar Full time

    QA/Expeditor - North Greenbush Chili's 101 Van Rensselaer Square Rensselaer, NY 12144 Min: $15.00 Hourly | Max: $17.50 Hourly Role Overview Our Quality Assurance Specialists ensure each Guest receives perfectly prepared, high-quality food. They provide dependable, fast service that is absolutely Chili's! If you take pride in great team work, then we want to...

  • Mes Production Specialist

    3 weeks ago

    Rensselaer, United States Regeneron Pharmaceuticals Inc. Full time

    **Summary**: Responsible for liaising with MES Operations and Manufacturing to ensure the continual generation, and revision, and approval of MES documentation documentation. Essential Duties and Responsibilities include, but are not limited to, the following: Supports MES builds by generating support documentation (e.g process flow map templates) from...

  • Compliance Specialist

    3 weeks ago

    Rensselaer, United States Eurofins USA PSS Insourcing Solutions Full time

    **Company Description** The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life...

  • Compliance Specialist

    2 months ago

    Rensselaer, United States Eurofins Scientific Full time

    Company Description The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance...

  • Compliance Specialist

    2 weeks ago

    Rensselaer, United States Eurofins Scientific Full time

    Company Description The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance...

  • Compliance Specialist

    4 weeks ago

    Rensselaer, United States Eurofins USA PSS Insourcing Solutions Full time

    Job DescriptionJob DescriptionCompany DescriptionThe work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also...

  • Field Trainer

    2 weeks ago

    Rensselaer, United States Lirio Resources Full time

    **You need to work here!** Lirio Resources | Better Together Lirio Resources is looking for exceptional people who have a passion for caregiving and helping others to live their best life! Our employees appreciate great benefits including: - Weekly pay with immediate direct deposit - Paid training and on-going support. - Generous PTO package with sick...