Lead Microbiologist

Lead Microbiologist
Analyzes environmental monitoring and microbiological trends. Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls in compliance with company Standard Operating Procedures (SOPs) & Regulatory Standards. Prepare and present technical microbiology and sterility assurance investigative and trend reports to management. Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations.
Responsibilities: Essential Duties
* Analyzes environmental monitoring and microbiological trends.
* Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls.
* Prepare and present technical microbiology and sterility assurance investigative and trend reports to management.
* Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations.
* Perform, lead, and schedule routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus, as necessary
* Performs technical review of test results for completeness and compliance to cGMP's to ensure that excellent documentation, controls and traceability are in place to maintain integrity.
* Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities.
* Prepares and reviews preparation of media, reagents, test samples and equipment as required.
* Proficient in finished product and raw material testing i.e. Sterility testing, LAL/endotoxin testing
* Proficient in Environmental Monitoring techniques.
* Proficient in Microbial Identification
* Understands and demonstrates aseptic technique.
* Support in Internal (RC, Third Party Consultants) & External audits by regulatory agencies, such as FDA, BOP, and DEA.
Expertise: Knowledge & Skills:
* Knowledge of good analytical and laboratory techniques, pharmacy preparations, cGMP's, GLP's, SOP's, USP and FDA requirements
* Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls
* Good analytical, writing, interpersonal, and organizational skills
* Ability to meet deadlines
* Must be able to work independently
* Strong communication skills
* Ability to demonstrate leadership skills
* Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
* Software packages supporting statistical data analysis, word processing, and project management
Qualifications - Experience/Training/Education/Etc: Required:
* B.S. degree in Microbiology or related industry
* 3 - 5 years' experience in Pharmaceutical / medical device industry
* Supervisory/Leadership experience is a desired but not required
This position will fill as soon as a qualified candidate is identified. Please apply today for immediate consideration to phoenix@apexlifesciences.com
EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.PDN-94ac8619-ea6c-462a-847b-f7978d94b2b2