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Regulated Product Specialist

AzentaIndianapolis, Indiana

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Job Description

Azenta Inc.

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job Title

Regulated Product Specialist

Job Description

How You’ll Add Value

The Biobank Regulated Product Specialist is responsible for processing, retrieving, and discarding irreplaceable biological samples and/or production pharmaceuticals as assigned.  The incumbent is accountable for performing all assigned tasks with full attention and accuracy to maintain the integrity of the sample and the storage processes.

What You’ll Do

Handle processing requests for pharmaceutical and biological samples defined as critical (radioactive, tissue for transplant, IVF, etc.) Shown Proficiency in Receiving of Shipments Provide oversight of receiving and shipping processes for pharmaceutical products and samples defined as critical. Displays advanced competency in all job functions of a Biobank Technician. Review QRs identified by team members and send initial notification to PM, TC, CC and client. Facilitate SMO requests from PMO and follow up. Track progress of requests. Assist with Inventory Control functions. Investigate nonconformances and facilitate change control requests as appropriate. Assist with various levels of training as assigned by Training Coordinator. Knowledge of the investigation processes. Demonstrated leadership and initiative in sample management

What You Will Bring

  • Associate Degree + 1 year demonstrated proficiency in a Biobank or regulated warehouse position.
  • OR HS Diploma + 3 years demonstrated proficiency in a Biobank or regulated warehouse position.
  • OR a minimum of 6 months accurately and efficiently performing functions of a Biobank Technician and is not currently on a Performance Improvement Plan (PIP)/Corrective Action Plan
  • Pharmacy Technician License, preferred
  • IATA Certified, preferred
  • Life Sciences Degree, preferred
  • GMP/GTP/CLIA Experience, preferred
  • Intermediate to advanced knowledge of Microsoft Excel.
  • Comprehensive understanding of pharmaceutical and sample management functions including the ability to problem solve.
  • Ability to take initiative as shown by involvement on projects.
  • Proven communication, interpersonal and teamwork skills.

Physical Requirements

  • Reaching/lifting/bending.
  • Ability to lift 50 pounds
  • Extended periods of standing or sitting
  • Right- and left-hand finger dexterity
  • Ability to discern colors or use of color correction glasses
  • Ability to work with refrigerants (e.g., dry ice and LNs) using proper PPE

Your Working Conditions: 

  • Employee will be working in an area with potentially infectious materials.
  • Employee will be responsible for maintaining a clean work environment and enforce and follow Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.
  • The position requires flexibility to report to either the Indianapolis or Plainfield facility based on business needs.

If any applicant is unable to complete an application or respond to a job opening because of a disability, please email at Recruiting@azenta.com for assistance. 

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.

United States Base Compensation: $22.00 - $28.00

The posted pay range for this position is an estimate based on current market data and internal pay structure. Final compensation may vary above or below this range depending on factors such as experience, education (including licensure and certifications),  qualifications, performance, and geographic location, among other relevant business or organizational needs.

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