Job Purpose

Reporting to the QC Manager, the QC Microbiologist shall enhance practices and promote a culture which is consistent with cGMP, cGLP and Health & Safety within a pharmaceutical laboratory environment.

The QC Microbiologist will perform equipment maintenance and if needed may perform sample testing including but not limited to raw materials, in-process items, finished product and stability samples according to established operating procedures.

Revises and updates standard operating procedures as needed. To undertake microbiological analysis and provide technical knowledge for the Quality Control department at Dechra Pharmaceuticals Manufacturing, Fort Worth, Texas.

Key Responsibilities

• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, FDA/CVM, HS&E, etc.).

• Initiate Laboratory Investigation (LIs), Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Checks for related work in Veeva.

• Undertake the microbiological analysis of raw materials, intermediate bulks, finished products, stability samples, water samples and environmental monitoring within a fast-paced Quality Control environment.

• Review the analysis completed by others, facilitate corrections / amendments, as necessary.

• Identify and facilitate the update of methodologies and best practices.

• Perform weekly water sampling and testing. Testing to include description, specific conductivity, TOC, total coliforms, and aerobic plate count.

• Preform Environmental Monitoring and microbial ID.

• Prepare media, keep track of microbiological inventory and organisms, use autoclave.

• Initiate Anomalous reports, OOS forms, Deviations, Change Controls, and Effectiveness Reviews for related work.

• Contributes to the development of the department and individuals through coaching, mentoring and formal training, as necessary.

• Write, review and revise SOPs, as required.

• Perform physical testing on QC samples.

• Support the QC Manager and Chemists, as directed in the execution of their duties.

• Abide by and champion the company’s values (Dedication, Enjoyment, Courage, Honesty, Ambition) in all aspects of the role, including interaction with co-workers and third parties.

• In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.

Key Performance Indicators

• Local and departmental metrics are effectively managed and in control.

• Responsibilities and accountabilities are fulfilled.

• Behaviours are in line with the Dechra Values.

• Delivery of personal and departmental objectives.

• Schedule Adherence

• QMS OTP

Our Ideal Candidate:

• Motivated and self-driven

• Strong coaching, mentoring, and training skills

• Quality-conscious and customer-oriented

• Proactive and results-oriented

• Champion of GLP and GMP standards

• Accurate, precise, and able to work independently

• Strong attention to detail with a focus on precision

• Strong teamwork and collaboration skills

• Effective communication skills with the ability to tailor messaging to different audiences

• Knowledge of and commitment to regulatory compliance

• Strong problem-solving and analytical abilities

• Pragmatic approach to decision-making with a focus on execution

• Experience with sterile and aseptic techniques

• Ability to train and support new analysts in metrology and microbiology-related activities

Skills and Experience

• Required: Bachelor's degree in Science (Microbiology, Chemistry, Biology, or related scientific discipline).

• Proficiency in Microsoft Excel.

• Strong computer literacy with excellent attention to detail, including document formatting and data accuracy.

• Experience working within GLP and GMP-regulated environments.

• Ability to accurately document test results and maintain laboratory records in compliance with quality and regulatory requirements.

• Strong organizational and time-management skills with the ability to manage multiple priorities.

• Understanding of USP chapters and regulatory requirements related to microbiological testing.

• Preferred: More than 1 year of experience performing microbiological techniques, including TAMC, TYMC, membrane filtration, and microscopy, within a pharmaceutical GMP environment.

• Preferred: 3 years of experience working in a pharmaceutical GMP-regulated environment.

• Familiarity with Environmental, Health & Safety (EHS) requirements and laboratory safety practices.