Quality Operations Technician

locations Roseville, Minnesota time type Full time posted on Posted 2 Days Ago job requisition id R0020716 About Ferring: By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we’re on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation. Job Description: Contribute to outstanding innovation + Make braver choices Location: Roseville, Minnesota
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year commitment to
science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Located in Roseville, Minnesota, our goal is to improve the lives of patients and reduce the cost of care associated with complex diseases through our innovative microbiota-based MRT™ drug platform. We are a passionate team of scientists, engineers, and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today’s medical needs. We are looking for like-minded get-it-done individuals to add to our growing team.
Summary: The Quality Operations Technician is responsible for performing thorough documentation review using internal procedures and controls, identifying any exceptions from approved procedures, performing physical disposition of material and product, executing material holds and rejects, supporting daily operations, and performing incoming inspections for excipients and components.
Responsibilities: Responsibilities include but are not limited to the following:

• Support daily operations activities, including:
  • Issue batch records
  • Perform incoming inspection of materials
  • Execute material Holds & Rejects
  • Support department Specialists on the manufacturing floor to monitor production activities and identify deviation from procedures.
• Perform thorough documentation review using internal procedure and controls, including:
  • Executed batch records for intermediate, drug substance and drug product
  • Testing records for source material, donor, and drug substance and drug product
  • Labelling
• Determine disposition of source material and intermediates.
• Execute physical disposition of incoming materials, intermediates, drug substance, and drug product, including:
  • Physically disposition materials and product
  • Create COAs & COCs
  • Support CTA Fax Back activities
• Support other Quality Operations & Quality Systems functions as required.

Requirements:

• Bachelor’s degree in a scientific field with 1or more years in the pharmaceutical and/or biopharmaceutical industry (or related regulated industry).
• Preferred previous experience in a Quality role with general understanding of manufacturing processes.
• Working knowledge of cGMPs.
• Preferred working knowledge of quality regulations including 21 CFR 210, 211, 600 & 610.
• Good oral and written skills, ability to function effectively in a team, and manage time efficiently
  
  Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.

Join our team and you’ll become part of a close-knit family – one in which you’ll be listened to and your contributions valued. Surrounded by like-minded people, you’ll have the support to achieve more. So, if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected
Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Roseville, Minnesota