Madison, Wisconsin
Quality Assurance (QA) Intern Job Opening in Madison, Wisconsin - BioTechnique is a contract manufacturing organization (CMO) dedicated to providing cytotoxic and high-potency sterile injectable fill-finish services in all stages of the drug life cycle ? from to final marketed product. We are located in Madison, Wisconsin.
BioTechnique is a subsidiary of PSC Biotech. PSC Biotech is one of the largest specialty life science consultancies and supports clients worldwide with a variety of comprehensive services that provide life science companies with the ability to perform at the highest standards and meet regulatory compliance requirements.
We are always looking for talented individuals to add to our team. We are currently recruiting for one QA Intern for our contract manufacturing organization cytotoxic fill-finish facility in Madison, Wisconsin. The QA Intern will be responsible for cGMP compliance function and provide support of manufacturing and packaging of sterile injectable products. This position will support the QA Associate and Quality Director in development and maintenance of Quality Systems including deviations / investigations, change control, auditing programs, CAPA, review and approval of controlled documents, and training.
Responsibilities
Maintain compliance in areas of document control and supplier control for company as well as clients in support of company?s strategic plan.
Batch record review
Final product inspections.
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Support quality investigations of manufacturing deviations, GMP issues, system issues, non-conforming materials, and CAPAs.
Review technical/ investigation reports as appropriate.
Provide support for proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Gather metric information for use in continuous improvement of areas of responsibility.
Provide on the floor support to manufacturing operation.
Requirements
Education Required:
Currently enrolled in a bachelors or masters degree program; preferably in science, engineering, biotechnology, or a related field. PhD program participation a plus.
Skills /Experience Required:
Ability to learn parenteral manufacturing environment (aseptic/sterile manufacturing).
Ability to learn quality systems and regulatory requirements (21 CRF Part 11/210/211).
Ability to learn and apply basic cGMP requirements.
Ability to learn cleanroom gowning procedures.
High attention to detail is required.
Effective verbal and written communication in English.
Familiar with using IT systems and programs, to include MS Office suite. Ability to quickly learn to use and effectively utilize process automation systems.
Reliable and trustworthy.
Ability to work in a fast paced, profit driven, manufacturing environment.
Job Type: Internship
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