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The Quality Control Microbiology Specialist will play a critical role in ensuring the safety, quality, and compliance of drug products through the execution of microbiological testing and monitoring programs. This position is responsible for conducting in-process environmental monitoring of cGMP manufacturing suites, performing finished product safety testing including endotoxin and sterility assays, and supporting stability programs to evaluate product performance over time. The Specialist will be expected to generate accurate, reliable, and timely data while maintaining compliance with SOPs, cGMP requirements, and regulatory expectations. In addition, this role will contribute to continuous improvement initiatives, support investigations, and partner with cross-functional teams to uphold high standards of product quality and patient safety. DUTIES AND RESPONSIBILITIES: The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.
- Perform in-process environmental monitoring of classified cGMP manufacturing suites, including routine viable and non-viable particulate testing.
- Execute finished product microbiological assays such as endotoxin and sterility testing in accordance with compendial methods and internal SOPs.
- Conduct stability testing to assess product quality and integrity throughout the product lifecycle.
- Ensure all laboratory activities are performed in compliance with cGMP, FDA, and other applicable regulatory requirements.
- Accurately document, analyze, and report test results in a timely manner while maintaining data integrity standards.
- Participate in investigations related to environmental monitoring excursions, out-of-specification (OOS) results, or deviations, and support implementation of corrective and preventive actions (CAPA).
- Collaborate with cross-functional partners in Manufacturing, Quality Assurance, and Technical Operations to support batch release and regulatory submissions.
- Maintain laboratory equipment, supplies, and aseptic practices to ensure a safe, compliant, and efficient work environment.
- Contribute to continuous improvement initiatives, including updates to SOPs, methods, and workflows, to enhance efficiency and compliance.
QUALIFICATIONS: REQUIRED:
- Bachelor's degree in Molecular Biology, Biomedical Sciences, Microbiology, or a related field.
- Minimum of 2 years of experience working in a GMP-regulated quality control laboratory within the pharmaceutical or biotechnology industry.
- Previous aseptic gowning qualification and experience supporting aseptic processing environments.
- Strong working knowledge of cGMP regulations, USP, and EP testing requirements.
- Proficiency in microbiological techniques including rapid microbiology methods, endotoxin testing, growth promotion, plate reads, and environmental monitoring.
- Demonstrated ability to perform time-critical in-process and finished product testing to support manufacturing and clinical trial timelines.
- Experience conducting laboratory investigations, preparing deviations, and supporting CAPA development.
- Ability to analyze and interpret data, prepare trending reports, and contribute to test method development and SOP revisions.
- Ability to work independently on assigned projects with limited supervision.
- Strong attention to detail, organizational skills, and commitment to data integrity and compliance.
DESIRABLE
- Hands-on experience with laboratory information management systems (LIMS) and electronic data capture tools such as MODA.
- Experience collaborating cross-functionally to support batch release and regulatory submissions.
- Familiarity with continuous improvement initiatives, including updates to methods, SOPs, and workflows.
COMPETENCIES:
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
- Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. PHYSICAL DEMANDS:
- Frequently required to stand
- Frequently required to walk.
- Frequently required to sit.
- Frequently required to talk or hear.
- Occasionally required to lift light weights (less than 25 pounds)
- Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
WORK ENVIRONMENT:
- The noise level in the work environment usually is quiet.
Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.
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US WorldMeds
Nov 03, 2025