Senior Specialist, Quality Assurance

Employer
Arranta Bio
Location
Gainesville, FL
Posted
Jul 03, 2021
Ref
85503-324676
Required Education
Bachelors Degree
Position Type
Full time

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

The Quality Assurance Sr. Specialist supports the day-to-day GMP manufacturing operation via execution of all operational elements of the Quality Management System (QMS), including but not limited to the Supplier Quality Management System and Risk Management System. The Sr. Specialist also supports the Validation Program at the GNV facility.  This person will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, Process and Analytical Development and clients to ensure cGMP compliance and establish a quality culture. This is a unique opportunity for a senior level quality professional to help build and grow the Quality Assurance organization in a dynamic and fast-paced CDMO environment.

ESSENTIAL RESPONSIBILITIES

  • Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including Supplier Quality Management and Risk Management System.
  • Review and approve Supplier Quality records and questionnaires. May lead or participate in supplier audits and Material Review Board activities.
  • Review and approve Validation documentation including commissioning and qualification for facilities, equipment, and utilities.
  • Review and approve Risk Assessments and maintain Risk Registers.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.

Experience and Skills

  • BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a QA position within the biological and/or pharmaceutical industry.
  • Ability to apply GMP regulations and international guidelines to all aspects of the position
  • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
  • Exceptional oral and written communication skills to all organization levels as well as clients and vendors
  • Strong organizational skills; able to prioritize and manage through complex processes/projects
  • Extensive experience with electronic systems, Supplier Management and Risk assessments and mitigation.
  • Ability to write reports, business correspondence and SOPs
  • Ability to be hands-on and detail orientated
  • Very proficient in MS Office application suite as well GMP electronic applications such as LIMS

 

PHYSICAL DEMANDS

• Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing –
writing,
• Ability to lift and carry 10 pounds
• The ability to gown and work successfully in a manufacturing environment

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)