Senior Quality Assurance Associate

Top 3 Must Have Skill Sets:1) cGMP experience2) Experience collaborating within and across functional areas and demonstrated customer service focus3) Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environmentDay to Day Responsibilities:1)Quality Oversight (including Purposeful Prescence on the Floor) of bulk drug substance manufacturing operations2)GMP documentation review/approval (including EURs, electronic logbooks, RT reports, Work Orders, batch records, etc.)3)Interim and reject cage managementEmployee Value Proposition:Responsibilities Include the Following:Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.Ensure that deviations from established procedures are documented per procedures.Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.Alert management of quality, compliance, supply and safety risks.Complete required assigned training to permit execution of required tasks.Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.Communicating and collaborating with the PQA shift to ensure required tasks are completedPreferred Qualifications:Bachelor’s degree and 2 years of Quality/Manufacturing work experienceExperience working in a cGMP environmentExperience with decision makingExperience with analytical testing and/or general compendia testingExperience working with batch records and other GMP documentationKnowledge of data integrity requirementsProficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)Experience collaborating within and across functional areas and demonstrated customer service focusExcellent written and verbal communication skillsAbility to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment