$100K — $150K *
Responsible for the routine supervision of the Microbiology group. Subject Matter Expert (SME) for microbiology related product and manufacturing investigations and Microbiology SOPs. Responsible for the training of operations’ personnel on aseptic techniques, identifying areas of improvement to maintain microbial levels within control in the lab and in manufacturing areas. Maintains the microbial environmental control program, trends and metrics and determine enhancements. Reviews and approves validation protocols regarding or involving microbial monitoring. Supports design and effective functionality of the Microbiology lab. Responsible for overseeing the execution of microbiology tests to evaluate environment, utilities, raw materials, in-process and drug product in accordance with approved methodologies, procedures, and cGMP regulations.
· Supervises assigned laboratory personnel and their daily work activities.
· Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action, as necessary, on a timely basis and in accordance with company policies and procedures.
· Interprets test results, compare them to established specifications and control limits, and makes recommendations on appropriateness of data for material release.
· Supports Operations in the conduct of scientifically sound microbiology related out-of-specification and non-conformance investigations and recommends corrective actions.
· Evaluates environmental monitoring data and variances. Notifies environmental Variances to impacted areas, recommends actions, and monitors actions for effectiveness and timeliness.
· Support Microbiology Test method, Equipment and instrument qualification.
· Collect and report monthly metrics.
· Update and create Microbiology area SOPs.
· Participate in the Plant activities for continuous improvements like walkthroughs etc. Coordinate activities to assure effective qualifications from the microbial stand point.
· Conducts routine and non-routine micro analyses of raw materials, in-process materials, finished goods and stability samples.
· Monitors testing procedures to ensure that all tests are performed according to established specifications, standard test methods, or protocols.
· Completes documentation needed to support testing procedures including data, forms and equipment logbooks.
· Performs data review and data reporting.
· Trains personnel in aseptic techniques and identifies areas of improvement to maintain microbial controls in production and lab areas.
· Ensures that laboratory safety standards are followed and maintained.
Participates in internal or external assessments and audits as required. Writes or revises microbiology standard operating procedures.
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Education and/or Experience
· Bachelor’s degree in Microbiology or equivalent. Advanced degree desirable.
· 10+ years of quality control experience in a pharmaceutical or biotech environment; at least 4 years executing data analysis and trending; 2+ years in a supervisory capacity.
· Subject Matter Expert (SME) for microbiology.
· Expertise in organism identification.
· Knowledge and understanding of cGMP regulations and good documentation and laboratory practices
· Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)
Limited travel but willing and able to travel if required, including internationally.
· Technical Capability
· Communication Proficiency
· Interpersonal Skills
· Organizational Skills
· Presentation Skills
· Problem Solving/Analysis
Romark Core Values
· Vision - Big vision, no limits; purpose-driven; ability to identify potential problems or impediments and to see through them
· Competence - Exceptional knowledge and understanding of the work we are called to do; exceptional critical thinking skills
· Ingenuity - Original, creative, clever, innovative, perceptive and/or intuitive in solving problems or meeting challenges
· Courage - Willingness to take calculated risks to accomplish a noble mission
· Passion - Intense compelling enthusiasm or desire to achieve our calling/fulfill our purpose
· Integrity - Having a clear vision and understanding of that which is right and doing it; being faithful to patients and healthcare professionals
· Relationships - Trusted business partners, engaging others with professionalism, grace and respect in valued long-term relationships
· Personal Responsibility - Leadership, dependability, doing our jobs and going beyond the call to ensure success of the organization
· Respect -Humility; exhibiting special appreciation for medicines, for our work, for the responsibilities and opportunities with which we have been entrusted
· Perseverance - "In it to win it" – steadfast despite difficulty or delay
· Excellence - Being outstanding or extremely good in everything we do
Valid through: 3/12/2021