Quality Assurance Associate at Gibson Bioscience in Lexington, Kentucky

Job Description:

We have a full-time position available supporting our Quality Department in Lexington. We are looking for a detail oriented person who is will be the primary responder to all filing for the Quality Department. This position also participates in revising documents, organizing files, and helping to design new systems. This position is also responsible for maintaining the SDS's books, distributing new revisions of documents, and removing obsolete documents, and responsible for all change order processes and training.
Key responsibilities in this role will include:
Release authority of incoming product inspection. Manage process validations, summarize data and write validation reports. Assist and support the organization's efforts to meet FDA QSR requirements and ISO 13485 conformity. Conduct Internal Audits both as an individual and as a team member. Perform and Maintain all Supplier evaluations or assessments per the approved supplier list. Perform Document Control functions and aid in assisting all employees with questions pertaining to all aspects of that system. Conduct special projects as needed. Assist in maintaining the necessary active documentation as well as archiving of documentation as set by the facilities Quality System. Primary Analyst for Electronic Change Order and Document Processing. Mentor and train employees on Document Control requirements as needed. Manage the CAPA process and perform CAPA Verifications. Manage CATSWeb employee list. Maintain metrics and communication board. Conduct internal audits and provide notes of audits performed in accordance with ISO Certifications. Assist auditing of batch (DHR) records and manufacturing procedures. Write standard operating procedures and forms related to operations. Assist in the maintenance of the Quality Manual. Assist with maintaining Master Device Records. Maintain document control in CATSWeb. Perform Batch (DHR) Record Reviews. Assist investigations of failures, non-conforming products, and deviations. Initiate disposition of defective products and materials. Regularly evaluate monitoring equipment. Manage and perform in-process testing of the product. Participate in audits by regulatory agencies. Maintain the Master Equipment Listing. Perform Calibration and Verification on in-house production equipment.Manage the Calibration Process: Scheduling for outside calibration.

Who is Microbiologics?

Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the worlds leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.

Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that "great vision without great people is irrelevant." That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.

What can we offer you?

Glad you asked!

We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few. In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth.

Where is this position located?

Lexington, Kentucky

Known as the Horse Capital of the World, the Lexington area is a gently rolling plateau in the center of the inner Bluegrass Region. The area is noted for its scenic beauty, fertile soil, excellent pastureland, and horse and stock farms. The city is set up like a wheel with spokes, with main arterial roads running from downtown out into horse country.

Lexington area is home to about 330,000 people There are over 230 churches and synagogues in Lexington, representing 38 denominations as well as mosques and a Hindu temple They are the heart of the Bluegrass Region and home to many Civil War sites and historic homes Lexington is home to an exploding culinary revolution and the Brewgrass Trail

What makes you a good fit?

Our goal is finding the right individual for our team we firmly believe that the right person is someone to invest in and invite to join our family.

Here is what we are looking for:
Four-year bachelor's degree (B.S.) or equivalent combination of education and experience. The ability to pass a background check and drug screening. Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required upon hire.