Quality Control Sample Management Lead

Employer
Arranta Bio
Location
Gainesville, FL
Posted
May 22, 2021
Ref
85503-320043
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Contract

ABOUT US

Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.

 WHO ARE WE

Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.

Here at Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.

We embrace our challenges as opportunities.

We are empowered to think and act.

We never settle; we strive to improve through purposeful creativity.

We build aligned teams who learn, grow, and deliver.

We are committed to building strong relationships.

 Are you ready to come ALIVE with a daring and intrepid team?  Don’t wait another minute; Apply today!

JOB SUMMARY

 Quality Control Sample Management Lead will organize, coordinate, and document sample management and stability activities for the quality control laboratory. This individual will ensure that quality control samples are received, allocated, and submitted appropriately per cGMP regulations. This position will also coordinate outsourced testing and ensure stability samples are retained and pulled according to standard procedures.

ESSENTIAL RESPONSIBILITIES

  • Actively participates in fostering a positive, collaborative work culture
  • Authoring and revision of standard operating procedures, forms, and logbooks.
  • Ensure systems are in place for sample receipt and tracking through the quality control laboratory workflow.
  • Coordinate shipment of outsourced quality control samples to external vendors
  • Request and file quotations of work, as well as line up purchase requests for external testing.
  • Create system for quality control sample storage
  • Data analysis and review
  • Some QC lab work may be involved
  • Maintain documentation in accordance with GDP
  • Other duties as assigned
  • Train and lead other analysts on proper storage and coordination of QC samples
  • Provide finished results to internal customers

Experience and Skills

 EDUCATION AND/ OR EXPERIENCE

  • B.S. degree in science or a life science-related field of study
  • 3-5 years of experience in Quality Control in GMP environment, preferably with experience in a microbiology laboratory 
  • Experience with sample management preferred
  • Experience with stability preferred
  • Experience with writing standard operating procedures
  • Familiarity with FDA, ICH, and EU Regulations and Guidelines
  • Involvement in continuous improvement initiatives and laboratory investigations
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
  • Proficiency in Microsoft Office suite applications

 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

  • Bending, standing, walking, lifting, sitting, carrying, stooping, crouching, kneeling repetitive motions typing- filing – writing 
  • Ability to lift and carry 25 pounds · Travel <10% 
  • This is a laboratory-based position that may require some non-standard working hours including early mornings or later evenings on weekdays and weekends to support global prospective and current clients.

BENEFITS

  • Phone reimbursement policy for qualified individuals
  • Free parking
  • Highly competitive healthcare with many plan options:
  • Medical (HMO/PPO/EPO)
    • Dental
    • vision
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Up to 10 weeks of 100% paid maternity leave
  • 2 weeks of 100% paid paternity, domestic partner, & adoption leave
  • Educational assistance program
  • 401k (traditional and Roth offered) with 100% match on first 5% deferred.
  • A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • Employee Referral program
  • Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)