Quality Control Data Manager

2 weeks ago


Andover, Massachusetts, United States Sarepta Therapeutics Full time

The QC Data Manager at Sarepta Therapeutics

  • Oversee review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing related to Sarepta's Gene Therapy pipeline.
  • Responsible for oversight and review of release and stability data, technical reports, and managing quality events.
  • Build and oversee a team of QC data reviewers responsible for various testing activities.
  • Work with internal teams to ensure timely closure of quality events and delivery of test data.
  • Ensure timely approval of Certificate of Analysis, Certificate of testing and technical reports.

Primary Responsibilities Include:

  • Review gene therapy product release and stability data internally.
  • Generate product release Certificate of Testing and associated GMP documentation.
  • Author and review Quality documents such as SOP, OOS/OOT, CAPA and Change Control.
  • Support review of test methods, development reports, study protocols, and validation reports.
  • Trend data for qualified materials, release products, and stability products.
  • Review scientific literature for incorporation into technical reports and laboratory investigations.

Desired Education and Skills:

  • BS degree in a scientific discipline with 5-8 years of related experience.
  • Experience in a cGMP environment and with gene therapies is preferred.
  • Understanding of various assays and molecular testing methods is highly desired.
  • Familiarity with regulatory guidelines and pharmacopeia is necessary.
  • Strong interpersonal skills, project management skills, and technical writing abilities are required.

This position offers a competitive compensation and benefit package.


  • Bench Scientist

    1 month ago


    Andover, Massachusetts, United States Pioneer Data Systems Full time

    Position Details: Our client, a world–leading Pharmaceutical Company in Andover, MA is currently looking for an Scientist I (Cell Culture, HPLC) to join their expanding team. Job Title: Scientist I (Cell Culture, HPLC) Duration: 18 months contract, extendable up to 36 monthsLocation:Andover, MANote: The client has the right–to–hire you as a permanent...

  • Bench Scientist

    4 weeks ago


    Andover, Massachusetts, United States Pioneer Data Systems Full time

    Position Details: Our client, a world–leading Pharmaceutical Company in Andover, MA is currently looking for an Scientist I (Cell Culture, HPLC) to join their expanding team. Job Title: Scientist I (Cell Culture, HPLC) Duration: 18 months contract, extendable up to 36 monthsLocation:Andover, MANote: The client has the right–to–hire you as a permanent...

  • Controller

    3 days ago


    Andover, Massachusetts, United States teamworkonline Full time

    3STEP Sports is the largest youth sport event and club operator in the nation, providing brands with the ability to impact more athletes than ever in a unique and authentic way. The 3STEP reach spans 40+ states and currently serves more than 3.2 million athletes. We deliver a premier, inspiring and authentic experience – dedicated to perfecting every...


  • Andover, Massachusetts, United States Raytheon Technologies Full time

    Date Posted: Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite About Us: At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the...


  • Andover, Massachusetts, United States Raytheon Technologies Full time

    Date Posted: Country: United States of America Location: MA114: Andover MA 354 Lowell Suffolk 354 Lowell Street Suffolk, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of...


  • Andover, Massachusetts, United States Straumann Full time

    #ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive change,...


  • Andover, Massachusetts, United States Straumann Full time

    #ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive change,...

  • Data Engineer

    4 weeks ago


    Andover, Massachusetts, United States Rockstar Full time

    At Rockstar Games, we create world-class entertainment experiences.A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated and inclusive environment where you can learn, and collaborate with some of the most...

  • Data Engineer

    1 month ago


    Andover, Massachusetts, United States Rockstar Full time

    At Rockstar Games, we create world-class entertainment experiences.A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated and inclusive environment where you can learn, and collaborate with some of the most...

  • Data Engineer

    4 weeks ago


    Andover, Massachusetts, United States Rockstar Full time

    At Rockstar Games, we create world-class entertainment experiences.A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated and inclusive environment where you can learn, and collaborate with some of the most...

  • Data Engineer

    2 months ago


    Andover, Massachusetts, United States Rockstar Full time

    At Rockstar Games, we create world-class entertainment experiences.A career at Rockstar Games is about being part of a team working on some of the most creatively rewarding and ambitious projects to be found in any entertainment medium. You would be welcomed to a dedicated and inclusive environment where you can learn, and collaborate with some of the most...

  • Project Manager

    2 weeks ago


    Andover, Massachusetts, United States AZ Full time

    Project Manager - Life Sciences Job Details Level Management Job Location Andover, MA - Andover, MA Position Type Full Time Education Level 4 Year Degree Travel Percentage Negligible Job Shift Any Job Category Construction Project Manager - Life Sciences POSITION SUMMARY: The Project Manager will report directly to the Division Operations Manager as...

  • Analytical Chemist

    1 month ago


    Andover, Massachusetts, United States Pioneer Data Systems Full time

    Position Details: Our client, a world–leading Pharmaceutical Company in Andover, MA is currently looking for an Analytical Chemist to join their expanding team. Job Title: Analytical Chemist (Protein Analysis) / Pharma Industry Duration: 17 months contractLocation: Andover, MAThis is a fully onsite position in Andover, MA Note: The client has the...

  • Analytical Chemist

    4 weeks ago


    Andover, Massachusetts, United States Pioneer Data Systems Full time

    Position Details: Our client, a world–leading Pharmaceutical Company in Andover, MA is currently looking for an Analytical Chemist to join their expanding team. Job Title: Analytical Chemist (Protein Analysis) / Pharma Industry Duration: 17 months contractLocation: Andover, MAThis is a fully onsite position in Andover, MA Note: The client has the...


  • Andover, Massachusetts, United States The Ladders Full time

    We're Watts. Together, we're reimagining the future of water. We feel proud every day about what we do. We're all part of the same crucial mission, no matter what function we support -- it's to provide safe, clean water for the world, and to protect our planet's most valuable resource. What we do: For 150 years, Watts has built best-in-class products that...

  • Manufacturing Manager

    4 weeks ago


    Andover, Massachusetts, United States RTX Corporation Full time

    Date Posted Country United States of America Location MA113: Andover MA 352 Lowell Hampshir 352 Lowell Street Hampshire, Andover, MA, 01810 USA Position Role Type Onsite About Us At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the...

  • Manufacturing Manager

    2 weeks ago


    Andover, Massachusetts, United States RTX Corporation Full time

    Date Posted Country United States of America Location MA113: Andover MA 352 Lowell Hampshir 352 Lowell Street Hampshire, Andover, MA, 01810 USA Position Role Type Onsite About Us At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the...

  • Program Manager

    2 weeks ago


    Andover, Massachusetts, United States Raytheon Technologies Full time

    Date Posted: Country:United States of AmericaLocation:MA114: Andover MA 354 Lowell Suffolk 354 Lowell Street Suffolk, Andover, MA, 01810 USAPosition Role Type:OnsiteAbout Us:At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength...

  • Property Manager

    2 weeks ago


    Andover, Massachusetts, United States Panco Management Full time

    The Point at Merrimack River is seeking an experinced Property Manager$1000 ONE TIME SIGN ON BONUSIf you are looking for an opportunity to join a company that cares about its people, here it is.At Panco Management, everyone is part of a team that feels like family. Together we work hard to deliver value to our residents by continuously investing in and...

  • Sr. Manager, FP&A

    1 month ago


    Andover, Massachusetts, United States Straumann Full time

    #ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive change,...