Quality Control Microbiology 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 QC Associate I to join our Microbiology team who will be responsible for performing routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables. 

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
  • Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.
  • Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.
  • Assist in trending EM data and generate quarterly reports and yearly reports.
  • Perform routine monitoring of pharmaceutical water systems.
  • Perform routine monitoring of pharmaceutical gas systems.
  • Perform bioburden and endotoxin testing.
  • Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.
  • Support assay transfer, qualification and validation activities for client’s specific methods.
  • Author and review Quality Control standard operating procedures (SOPs) and assay qualifications.
  • Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities. 
  • Interact closely with other departments to ensure efficient, compliant and timely execution of project activities.
  • Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.
  • Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
  • Safely operate laboratory equipment in accordance with established practices.

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 degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
  • 0-3 years of experience in environmental monitoring of GMP facilities. 
  • 0-3 years of experience working in a GMP microbiology lab.
  • Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices.
  • Experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.
  • Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.
  • Ability to gown qualify  and work in a cleanroom environment.
  • Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
  • Ability to use routine laboratory equipment including, but not limited to, particle counters, air samplers, microscopes, etc.
  • Ability to work well under pressure, multi-task, and have good organizational and communication skills.
Nice to Have 
  • Experience using LIMS 
  • Experience operating an autoclave and/or isolator
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.  Ability to carry/lift/push and/or pull upwards of 15 lbs on a frequent basis. 

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.