Manager / Senior Manager, QA Analytical

divh2QA Analytical Manager / h2pManage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivates and maintains Quality Assurance staff by recruiting, training, and managing QA team members. Align QA Analytical organization to meet companys strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial. / ppLeads and directs the QA Analytical team supporting analytical testing operations. Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities. Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents. Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required. / ppKnowledge, Skills, Abilities / pulliBS in scientific field with 8+ years experience or MS and 6+ years experience in a QA or GMP environment or equivalent. Experience in a in a QA role supporting GMP analytical testing is required. Minimum of 2 years of supervisory experience. / liliStrong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs and knowledge of US, EU and Row cGMP guidelines. / liliExperience with electronic laboratory information management systems is preferred. / li / ulpLanguage / pulliAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. / liliAbility to write reports, business correspondence, and procedure manuals. / liliAbility to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. / li / ulpReasoning Ability / pulliAbility to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. / liliAbility to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. / li / ulpMath Ability / pulliBasic math skills are required. Ability to apply concepts of basic algebra and statistics. / li / ulpPhysical Demands / pulliSupport manufacturing and warehouse operations to include movement and / or lifting of raw materials and consumables. / li / ulpComputer Skills / pulliKnowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management / li / ulpEquipment / pulliKnowledge of and experience using a computer, a telephone / li / ulpKBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs. / ppKBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. / p / div