Location:
Watertown, MA
Employment Type:
Full-Time
Salary:
Competitive
Job Description
Sr. Quality Assurance Specialist
Selecta Biosciences is seeking a talented Sr. Quality Assurance Specialist to join our fast paced and growing company! Selecta Biosciences is a clinical-stage biopharmaceutical company developing targeted immunotherapies and vaccines that are designed to modulate immune responses to treat and prevent disease. Selecta’s proprietary Synthetic Vaccine Particle (SVP™) platform has the potential to create a new paradigm in immunology and may enable a novel approach for selectively targeting the immune system to effectively and safely treat and prevent rare and serious diseases.
SUMMARY
This position will be responsible for assisting the Senior Director of QA with all aspects of Quality Assurance at Selecta Biosciences. This includes ensuring compliance with applicable regulations and/or guidelines from FDA, EMA, and ICH including GMP and GLP standards for preclinical and clinical development programs.
PRINCIPAL DUTIES/RESPONSIBILITIES
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Maintain Selecta’s QA files.
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Review CMO’s manufacturing batch records and analytical records.
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Participate in review of CMO’s manufacturing process validations, equipment qualifications and analytical method validations.
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Participate in vendor qualifications, including conducting off-site audits and audit report writing.
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Develop and write SOP’s and technical reports.
Requirements
EDUCATIONAL AND/OR EXPERIENCE
Bachelor’s Degree with a minimum of 5 years’ of Quality Assurance experience in pharmaceutical/biotech/life sciences required. Experience with sterile products desirable and experience with particulate and/or polymeric systems a plus.
Additional requirements include:
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Experience in developing, writing, and reviewing SOP’s
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Experience in conducting internal and external audits for GMP and GLP compliance as applicable
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Experience in working with Part 11-compliant document management software systems
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Excellent written and verbal communication skills and ability to work effectively in cross functional teams, peers, management and site personnel
WORK ENVIRONMENT
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An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Company policies, rules, and regulations in these as is required.
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While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require long periods of standing.
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The Company has active programs on developing novel immunotherapies for various food and environmental allergies. An employee may be required to work with and/or be exposed to allergens in the laboratory.
Qualified candidates should send a resume to:http://www.companycareersite.com/lmgr.aspx?l=~CS3MGT. Please refer to Job Code 17006 when corresponding about this position.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/
Visit us at: www.selectabio.com
NO PHONE CALLS OR AGENCIES PLEASE