Quality Analyst II, Microbiology and Raw Materials
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POST DATE 6/4/2020
END DATE 8/4/2020
JOB DESCRIPTIONPosition Summary:
As a Quality Analyst II, you will support the comprehensive quality activities, including entering, tracking and trending Microbiology and Raw Material data, managing timelines while ensuring the production environment is in a state of readiness. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.
Job Duties Summary:
As a Quality Analyst II, you will support the daily operations of the Microbiology Lab and Raw Material Lab. You will need to complete documentation, data entry, and data review for your testing data in a timely manner.
Supports the daily operations of the Raw Material, Microbiology, Manufacturing, and Process Development groups.
Responsible for performing a wide variety of analytical testing methods including but not limited to raw material testing and microbiology assays.
Operates and maintains lab equipment as required by SOPs and testing procedures
Responsible for initiating, investigating, resolving and completing event records within our controlled event system TRACKWISE.
Support SOP revision processes and other related documentation as needed.
Support the protocol and final report preparation for special studies and projects as needed.
Prioritize tasks to ensure that projects are completed by the assigned deadlines.
Support team building by participating in interviewing new talent.
Comply with company EH&S requirements. Promote a safety-first culture.
Education Level and Languages Required
BS degree or higher in a Life Science discipline or equivalent.
BA/BS in scientific discipline with 1 or more years of relevant experience
High School Diploma or Associate Degree in a Life Science discipline plus a minimum of 2-3 year of relevant experience.
Professional Skills, Qualifications and Experience
Previous experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, automation, troubleshooting for machineries, equipment, software and data integrity is a plus.
Good understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals is a plus.
Knowledge of Aseptic Technique and Gowning is a plus
Physical Requirements (PPE, lifting)
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, the employee is:
Constantly required to sit and reach to use computers and other office/lab equipment
Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
Occasionally required to lift up to fifty (50) pounds
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. The employee may be required to conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.