Sr. Quality Control Scientist/Pathologist
The Sr. Quality Control Scientist will be part of the Quality team and responsible for performing various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.
Who you are:
In this role you will evaluate stained IHC slides generated from routine product testing, stability testing and/or investigation testing, support QC analysts in troubleshooting suspect testing results, recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process, maintain cGMP compliance, support Medical Office and Research & Development as needed as well as; maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines, write, revise and/or review Standard Operating Procedures while adhering to regulatory requirements. You may be required to work on various projects to improve efficiency or compliance, recommend, provide, or initiate solutions by actively providing suggestions for improvement.
The individual must be detail-oriented and disciplined to adhere to strict deadlines, maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management, be willing and able to work on weekends or extended hours as needed and complete other duties as assigned or required.
· Master of Science degree or higher in biological or life sciences
· 2+ years’ experience in an FDA QSRs cGMP, and ISO 13485 OR any additional regulated environment
· 2+ years’ experience of Quality Control experience
· 2+ years’ experience in immunohistochemistry (IHC), pathology or clinical science
· 2+ years’ experience in evaluating stained IHC slides
· Pathologist with 2+yrs highly preferred
· Licensure/Certification preferred (histotechnologist or histotechnician)
· Focus in pathology preferred
Job Requisition ID: 197295
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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