Sr. QA Specialist

Employer
Arranta Bio
Location
Gainesville, FL, United States
Posted
Oct 23, 2020
Ref
85503-312293
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 Sr. Quality Assurance Specialist supports the day-to-day early phase clinical GMP manufacturing operation via execution of all operational elements of the Quality Management System (QMS), including but not limited to deviations, corrective and preventive actions (CAPAs), investigations, excursions, out of specifications (OOS), change control, batch review and disposition, and training in support of biologics manufacturing production. He/She 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 to help build and grow the QA Operations 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, but not limited to, deviations, change controls, and CAPAs.
  • Lead Quality Management Systems such as CAPAs, Deviations, and/or Change Controls. Ensure systems are implemented in an effective manner.


  • Develop and maintain key performance indicators to assess performance, quantify the impact of improvement efforts and to identify potential?areas for?further quality improvement
  • Contribute to quality council and operational meetings to oversee matters related to product quality and GMP compliance
  • Develop new procedures and processes, write SOPs, and train staff.
  • Review and approve batch records.
  • Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.


  • Review and approve preventative maintenance, calibration, and work order documentation.
  • Assist in and review root cause investigation for deviations and other quality events.
  • Provide on-the-floor QA support for manufacturing activities.
  • Represent Quality Assurance on client project teams, internal project teams, and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures. Train personnel on best practices.


  • Other duties as assigned


Experience and Skills

EDUCATION AND/ OR EXPERIENCE

  • BS required, MS preferred in a scientific/technical discipline with 5+ 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 writing and managing investigations and risk assessments
  • 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
  • A flexible work schedule is required
  • Ability to lift up to 25 lbs