[Remote] Quality Assurance Engineer

Note: The job is a remote job and is open to candidates in USA. DifGen Pharmaceuticals is a pharmaceutical manufacturer focused on innovative drug delivery technologies. They are seeking a Quality Assurance Engineer to become the subject matter expert for compliance related to production operations, assist with incident and deviation investigations, and provide quality assurance support across various departments.ResponsibilitiesReviews and approves Investigations for product quality deviationsReviews validation and qualification documentsBecomes Subject matter expert for company product line, production equipment, batch records and relevant SOP’sReviews and analyzes documents and data such as batch records, lab testing, finished product material statuses so as to support completion of the investigation processServes as an investigation team leader so as to assess impact on product quality and validation statusRecommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunitiesEnsures compliance with GMP’sProvides training and mentoring to colleagues performing investigationsWrites/revises SOPs relevant to the position’s responsibilitiesWorking with the Production Quality team, assess events when they arise to determine ability to resume productionInterpret specifications, standard operating procedures, and standard testing proceduresResponsible for the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records, formulation spreadsheets and Standard Operating procedures (SOPs) in support of research projects involving pharmaceutical components and/or drug products components and/or drug productsPerforms assessments / approvals of change controls related to production activitiesEnsures compliance with all Company policies and procedures including safety rules and regulationsOperates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirementsPerforms all work in support of our Values: Innovate, Evolve, and ExcelAll other relevant duties as assignedSkillsA Bachelor's degree in Engineering or Life Sciences from an accredited college or university with a minimum of 5 - 8 years experienceMaster's degree and 3-5 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is requiredKnowledge of GMP's (21CFR Parts 210 and 211)Analyzing and troubleshooting problems, identifying root causes and recommending and implementing effective methods, procedures, systems and/or techniquesAbility to prepare / edit all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.)Sound knowledge of the FDA, Health Canada, and other pharmaceutical regulationsThorough understanding of GMPs, specifically those relating to good documentation practicesAbility to analyze and interpret analytical dataInterpret specifications, standard operating procedures, and standard testing proceduresStrong organizational skillsManaging multiple projects, duties, and assignmentsWriting and interaction in EnglishPreferred Bachelor's degree (B.S.) in chemistry or related field with at least 5-8 years of experience in pharmaceutical analytical laboratory with transdermal laboratory experience, or Master's degree (M.S.) with at least 3-5 years of experienceKnowledgeable in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etcKnowledgeable in analytical testing of API, excipients and components following compendial and validated methodsAnalytical chemistry and common instrumentationCompany OverviewDifGen Pharmaceuticals is a pharmaceutical firm that focuses on difficult and differentiated generics. It was founded in undefined, and is headquartered in Princeton, New Jersey, USA, with a workforce of 201-500 employees. Its website is https://difgen.com.