QUALITY ASSURANCE ASSOCIATES - VALIDATION

AppTec offers comprehensive testing, contract research and development and cGMP manufacturing services for biopharmaceuticals, medical devices, cellular therapeutics and tissue-based products from a unique single-source platform. Our Philadelphia site is located in a new facility at the Philadelphia Navy Yard Business Center.

Due to our rapidly expanding portfolio of clients and projects, our Philadelphia site’s QA Department seeks experienced Quality Assurance Validation Associates. You will support Manufacturing and Testing operations as they relate to the validation of equipment (IQ/OQ/PQ), CIP, and SIP for biological clinical products. Duties include the execution, review and approval of various protocols, troubleshooting equipment, authorship and review of SOPs and writing, review and evaluation for appropriate action discrepancies / observations. You will also assist with client based audits, manage special projects as assigned and interact with a variety of internal departments.
REQUIREMENTS
BA/BS in Engineering, Biological Sciences or Chemistry and three to six years of validation/QA experience or equivalent training and/or experience is required. You should also possess good computer skills, excellent verbal and written communication skills and strong interpersonal skills to be able to effectively interact within multidisciplinary groups. The qualified candidate will also be a self-starter with the ability to multi-task, have strong attention to detail and solid organizational and problem solving skills. You must have a high level of personal integrity, be decisive and work effectively under pressure. Experience in pharmaceutical/aseptic processes as it relates to validation; environmental monitoring or clean room experience is desired.

If you are interested in joining our dynamic team, apply via e-mail link. We are an Equal Opportunity Employer. Direct applicants only - no agencies please. Visit us at: apptec-usa.com



QA, quality assurance, validation, GMP, cGMP, GLP.