Inspection & Compliance Associate

Sanford, NC, USA
Career Opportunity 
Your Vision. Our Mission. For Patients.

Abzena is proudly opening a brand new, state of the art manufacturing facility in Sanford, NC. We are seeking a QA Associate II, QA Inspection and Compliance to join our QA team who will be responsible for implementing change, as required, reviewing SOPs and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and cGMP requirements.
 
As a new state of the art facility, you will be a pioneer of our organization. If you meet our qualifications, find joy in doing this type of work for partners and towards treatment for patients, and would like to be part of an inclusive, agile, and learning culture - we would like to hear from you!

Responsibilities
  • Review SOPs, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.
  • Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices. 
  • Assists with preparing GMP training to cross-functional departments. 
  • Assists with executing and maintaining internal/external audit programs.
    • Assists with preparation of internal and external audit schedules, plans, and reports.
    • Maintains an efficient audit and corrective action tracking system.
    • Conducts comprehensive internal and external audits in accordance with written procedures to verify the adequacy and effectiveness of procedures and processes.
  • Assists with maintaining the customer audit process.
    • Prepares document requests in accordance with customer audit agenda.
    • Collaborates with internal departments to ensure effective customer audit responses/corrective actions are generated in a timely manner.
    • Performs Corrective Action follow-ups to ensure that commitments to our clients are completed as agreed in the customer audit responses.
    • Coordinates solutions for corrective actions and process improvements.
  • Coordinate and track risk assessments. 
  • Writes, reviews, and approves discrepancy reports (e.g., deviations, CAPAs, etc.).
  • Performs regular follow-ups and tracks discrepancy reports to closure. 
  • Assists with executing and maintaining Electronic Management Systems as it relates to Quality.
  • Performs other related duties as assigned. 
Qualifications
Mindset and Behaviors
  • Exemplifies a growth mindset.
  • Thrives in a start-up, agile work environment.
  • Thrives in a diverse, inclusive, team-centric environment.
  • Passionate about learning and open to feedback. 
  • Believes in shared accountability across functions and levels.
  • Described as curious, organized, resourceful, and thoughtful.
  • Operates to the highest ethical and moral standards.
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
Must-Have 
  • BS/BA degree or related work experience.
  • Minimum of two (2) to four (4) years’ experience in a GMP-oriented environment and Quality Assurance.
  • Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
  • Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development.
  • Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies. 
  • Skill in writing to effectively communicate complex ideas and concepts. 
  • Detail oriented with strong analytical, written, and verbal communication skills.
  • Must be familiar with Microsoft Office applications.
  • Ability to work well under pressure, independently, multi-task, be organized and have good communication skills. 
Work Schedule and Travel Requirement
  • Regular business hours 
Physical/Mental Requirement
  • Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.  Capable of accessing the manufacturing areas as needed. 
Great Benefits:
  • 100% Employer Paid Health, Dental, and Vision Benefits
  • 100% Employer Paid Basic Life & AD&D, Short-Term Disability, Employee Assistance Program
  • 5% 401k Employer Contribution through Fidelity
  • 23 Days of Paid Time Off, increasing to 28 days after 5 years of employees
  • Tuition Fee Reimbursement up to $5, 250 per year for degree, certification, development programs
Abzena is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identify and expression, parental status, protected veteran status, disability/handicap status, national origin, age, disability, citizenship status, marital status or any other characteristics protected by applicable laws, regulations and ordinances.