Manufacturing Quality Assurance Analyst

To be considered for this position please complete the following application: Manufacturing Quality Assurance Analyst 

SUMMARY:

We are seeking a Quality Assurance Analyst to join our growing Biomeme team. This person will be responsible for maintenance and organization of incoming raw goods and materials for lyophilization manufacturing as well as quality control testing and documentation for product in accordance with Biomeme SOPs and MPIs, as well as general regulatory guidelines. This position will report directly to the Lyophilization Manufacturing Lead and assist the Lead in adherence to Biomeme quality system requirements. 

 

RESPONSIBILITIES:

– Organizes and maintains incoming materials and inspections to ensure smooth flow of materials to production processes 

– Organizes and performs product QC analysis 

– Completes and maintans documentation related to assigned work, including logbooks, batch records, etc. 

– Adheres to SOPs and MPIs for all processes

– Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations 

– Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPS

– Reviews and revises pertinent SOPs and production batch records as required

– Inspire and constantly strive to make Biomeme a great place to work and respected for the quality of its people, products, and clients 

 

REQUIREMENTS:

– BA/BS degree in Biology, Chemistry, Biochemical Engineering, or related field 

– 1+ years of work experience

– Familiarity with principles of quality control 

– Preferred: 2-4+ years of laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education

 

SKILLS: 

– Organizational skills

– General laboratory skills

– Ability to work independently, as well as, participate on teams comprised of immediate group members, or to work cross functionally, in a fast-paced laboratory environment

– Skilled at organizing and prioritizing assigned tasks to assure completion 

– Can translate ideas on how to improve work tasks 

– Strong verbal and written skills

 

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