Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The qualified candidate must have training and experience with molecular based techniques, including isolation of DNA and RNA templates, reverse transcriptase PCR, and qPCR. The candidate to meet aggressive timelines within the Quality Science and Technology and Quality Control Microbiology groups. Participate in the routine testing of samples that required PCR based assay. May potentially participate in instrument validation, as needed, and method validation, in PCR based technologies. The candidate will be able to provide results and understand if the assay is valid or invalid. Candidate will be able to support any deviations or laboratory investigations in support of the PCR based assays. The candidate will be able to represent the Quality Control Microbiology group at internal meetings. Candidate will be available to work either Saturday or Sunday and four weekdays.

How You Will Achieve It

• Performs all work in compliance with cGMPs and site requirements.
• Performs DNA and/or RNA extraction and PCR -based assays, including RT-PCR, ddPCR and qPCR, for the routine testing and qualification/validation of new methods.
• Support product investigations, method improvements, troubleshooting for PCR-based assays and other assays as needed.
• Support instrument validation activities for Quality Science and Technology, focused on PCR instrumentation.
• Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems.
• 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.
• May train less experienced analysts in existing procedures, techniques, and governmental regulations.
• Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.
• Responsible for working either Saturday or Sunday once fully trained.

Qualifications:

Must Have

• Applicant must have High School Diploma (or Equivalent) with six years of relevant experience;
• OR an Associate's degree with four years of experience;
• OR a Bachelor's degree with 0+ years of experience.
• Molecular technique experience, preferably in the biopharmaceutical industry.
• Good understanding/knowledge and practical application of relevant techniques associated with PCR/qPCR and classical molecular techniques.
• Demonstrated aptitude to perform qPCR assays and analyze PCR data.
• Preferred to have proven record of technical writing skills, such as lab investigations, scientific reports, publications, journal articles, technical papers, method validation reports, etc.
• Demonstrated ability to independently perform routine tasks and engage in a team that is highly dynamic and fast paced.
• Proficiency with MS Word and Excel

Nice to Have

• Preferred to have proven record of technical writing skills, such as lab investigations, scientific reports, publications, journal articles, technical papers, method validation reports, etc.
• cGMP experience is a plus but not required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is a mixture of lab and office, approximately 60-80% of the time will be spent in the laboratory. Laboratory duties such as equipment cleaning, and maintenance may be required.

• This is a dedicated partial weekend position as well as 4 days during the week. The 4 weekdays days during the week are flexible, but the chosen candidate can choose either a Tuesday- Saturday or Sunday-Thursday schedule once fully trained.
• Candidate must be available to work either Saturday or Sunday.

PHYSICAL/MENTAL REQUIREMENTS

May include light lifting. Candidate must be able to perform mathematical calculations and complex data analysis specific to job responsibilities. Candidate must be able to work multiple hours performing pipetting, and in a Biosafety cabinet (BSC).

Work Location Assignment: On Premise

Relocation Assistance Available:

Last date to apply:

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

Quality Assurance and Control#LI-PFE