Qc Scientist Iv Jobs

Inclusively is partnering with a pharmaceutical and biotechnology corporationdescription to hire a QC Scientist IV.

ABOUT INCLUSIVELY:

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

• Mentors analysts by providing technical knowledge and support in resolving technical problems.
• Performs all work in compliance with cGMPs and site requirements.
• Lead/Support instrument validation activities.
• Carries out technical and administrative duties as needed.
• Perform microbiological assays and PCR-based assays for routine testing and qualification/validation of new methods.
• 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.
• Leads/Suggests continuous improvements to systems, procedures, etc.
• Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner.
• 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.
• Accountable for the accuracy and validity of testing results. Reviews and validates data.
• Trains less experienced analysts in new and existing procedures, techniques and governmental regulations.

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.
• 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.
• 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

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

• Eligible for Relocation Package: NO
• Last Date to Apply for Job: August 8, 2023
• Referral Bonus Eligibility: YES

Relocation assistance may be available based on business needs and/or eligibility.

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In person