QA Complaints Specialists (Newtown, PA) – Develop and implement regulatory compliance strategies for the company’s research, development, and manufacture of generic pharmaceutical products applying ANDA 21 CFR Part 210 and 211; Review/Issuance of Master Batch Records and qualification Protocols (IQ/OP/PQ) in compliance with cGMP/FDA/OSHA/EPA/DEA regulations and standard design; Develop, review, and implement drug complaint investigation activities applying GDP and ICH; Prepare and review Annual Product Quality Review Reports; Prepare and facilitate submission of Field Alert Reports (FAR)/Product Recalls; Initiate/Review and track GMP compliance and approval of Deviations, Change Controls and CAPA for production processes, facilities, and equipments; Compile and review QMS data for quarterly Quality Council presentations; Participate in FDA regulatory audits. Must have a Master’s Degree in Chemistry, Pharmaceutical Science, or Pharmaceutical Technology plus skills and knowledge of CAPA, Change Control, Regulatory Audits, 21 CFR, GDP, ICH, IQ/OQ/PQ, ANDA. Job location: Newtown, PA. Submit résumé referencing job code ANS011 to HR, KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940.