Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.
How You Will Achieve It
- Performs all work in compliance with cGMPs and site requirements.
- Perform microbiological assays and PCR-based assays for routine testing and qualification/validation of new methods.
- Lead/Support product method improvements, troubleshooting for PCR-based assays and other assays as needed.
- Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation to resolve and correct.
- Lead/Support instrument validation activities.
- Accountable for the accuracy and validity of testing results. Reviews and validates data.
- Interprets results, performs or reviews mathematical calculations, and records observations using Laboratory notebooks or other controlled documentation.
- Ensures that technical reports are prepared in a timely manner and reviews these reports for technical accuracy and compliance.
- Trains less experienced analysts in new and existing procedures, techniques and governmental regulations.
- Mentors analysts by providing technical knowledge and support in resolving technical problems.
- Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner.
- Leads/Suggests continuous improvements to systems, procedures, etc.
- Carries out technical and administrative duties as needed.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) and 8+ years of relevant experience OR an associate´s degree with 6+ years of experience OR a bachelor´s degree with 3+ years of experience OR a Master’s degree with 1+ years of experience.
- High technical knowledge and practical application of relevant techniques – classical microbiology techniques
- Demonstrated ability to independently document and troubleshoot methods
- Proficiency with Labware LIMS, MS Word and Excel.
- cGMP experience is required
- Experience with novel rapid microbial technologies such as PCR or rapid bioburden
- Knowledge of governmental regulations, specifically focused on Microbiological regulations
- Solid experience with technical writing, such as scientific reports, technical papers, method validation reports, regulatory filings, etc.
Nice-to-Have
- Experience leading continuous improvement projects
- Experience defending laboratory practices in regulatory audit.
PHYSICAL/MENTAL REQUIREMENTS
Position is a mixture of lab and office, approximately 50-75% of the time will be spent in the laboratory. Laboratory duties such as equipment cleaning, and maintenance may be required. Occasional weekend work may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some Holiday and off hour support may be required to support review and/or testing needs.
Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: August 8, 2023
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
Relocation assistance may be available based on business needs and/or eligibility.
Job Type: Full-time
Schedule:
Work Location: In person
Looking for more jobs near me. Find your favorite job now by visiting our jobs page.
