Associate Scientist III Microbiology

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Job Description
Position Summary
The Associate Scientist III, Microbiology is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assist in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and cleanroom qualification efforts. The Associate Scientist III, Microbiology participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Associate Scientist III, Microbiology may serve as a primary technical contact with clients. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Essential Functions
Maintains advanced knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned task.
Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisors instructions.
Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition.
Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
Examines physiological, morphological, and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
Prepares technical write up and assist in report generation as needed. Offer conclusions and recommendations based upon study outcomes.
Accurately completes GMP reviews.
Participates actively in lab investigations and corrective and preventative actions.
Trains others on individual core technologies.
Interacts with clients.
Initiates procedural revisions and perform editing and review functions.
Performs method development and validation independently.
Participates in process improvements.
Participates in company training and maintain current status of certifications.
Complies with applicable GMPs.
Provides technical training and leadership for subordinate technical positions.
Maintains a safe, clean, and organized work environment free from safety hazards.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
Bachelor’s Degree in Chemistry, Biology or Microbiology with 5 years of related experience.
Course work in Microbiology expected.
Other combinations of education and experience may be considered as equivalent at the discretion of Human Resources and the hiring Manager.
Alcami Non-Negotiables
Consistently demonstrates honesty and integrity through personal example.
Follows all safety policies and leads by example a safety first culture.
Produces high quality work product with a focus on first time right.
Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
Functional Competencies
Knowledge of Chemistry and Biology plus course work in Microbiology.
Basic and complex mathematical functions.
Applicable GMP regulations.
General computer program operations Inc., Word, Excel, Outlook.
SAP project status and CATS time entry functions.
NovaManage functions – look up and print documents, document editing and annotating.
Applicable lab standard operating procedures.
Strong familiarity with classes of organisms.
Strong microbial taxonomy procedures.
In-depth understanding of microbiology test procedures including: preservative effectiveness, sterility testing, bacterial endotoxins, microbial limits, antimicrobial effectiveness, compendial regulation/methods.
Basic theory of microbiology test procedures and validation.
Understanding of methods for environmental monitoring.
Automated microbial taxonomy procedures including advanced familiarity of microorganism colony and microscopic morphology.
In-depth understanding of microbiology method validation.
Familiar with changes in compendial microbiology methods.
Able to perform and understand trending of environmental monitoring data.
Proper documentation practices.
Execute procedures as written.
Recognize deviations from procedures and need for investigations.
Excellent aseptic techniques.
Independent use of more complex lab equipment.
Independently perform routine microbiological test procedures.
Assist in investigations.
Mentor less experienced analysts.
Perform environmental monitoring.
Independently perform complex methods.
Independently perform method development and validation studies.
Write test methods with supervision.
Assist in the preparation of scientific preparations.
Trend environmental monitoring results.
Decision Making and Supervision Required
Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
Receives minimal instruction on day-to-day work, general instructions on new assignments.
Travel Requirements
Up to 10% domestic travel.
Physical Demands and Work Environment
The physical demands 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. While performing the duties of this job, the employee is required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance and taste or smell. The employee must frequently lift and/or move up to 10 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.
Job Requirements
(see job description above)

Company info

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