QA Chemist

KVK Tech is looking for a QA Chemist to join our team in Newtown, PA. This position's responsibilities will include, but not be limited to the following: Conduct core quality system audits including investigations of any deviations, change control, and CAPA; Perform quality assurance analysis of raw materials, in-process materials; Perform stability analysis; conduct identification tests of raw materials as instructed using UVNis, Spectrophotometer, NIR, etc. and perform assay of finished products using HPLC and Titrimetry; Perform scientific and analytical testing of products for stability & prepare stability study reports to ensure robustness of product and validation of shelf life; Compile scientific research and development reports, batch records, PDR, and ANDA submissions in compliance with 21 CFR and prepare technical reports on compliance with 21 CFR regulations in manufacturing/packaging processes; Develop and design IQ/OQ/PQ protocols according to 21 CFR for all equipment as per VMP; draft SOPs; conduct final inspections of Batch Manufacturing Records for product release; test parameters for tablets including hardness testing, friability testing, disintegration, and thickness studies, etc. among others. Benefits Include: 401(k) with matching; Health, Vision, Dental Insurance; Childcare Scholarship; Tuition Reimbursement; Bonus Pay + Merit Increases; Paid Time Off; Flexible Holidays. We Are Looking For Applicants With: Bachelor's degree or foreign equivalent in Chemistry/Pharmaceutical Science or related field; Three (3) years relevant work experience required. KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation, or any other protected status.

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