Principal Associate I, Plant Quality Assurance - 2ND SHIFT

The Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. This position will be required to proactively support cGMP compliance and interact with all departments within the company. This position interacts with production staff and other cross functional groups routinely. This is a 2nd shift opportunity, 4-day (Mon – Thurs) 10-hour shift schedule. This position is based in our Framingham location and typically has a 4-day on-site expectation.

Responsibilities

Serve as the second shift QA lead working alongside manufacturing teams to ensure current and best practices are implemented, consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate and regulatory quality requirements; Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment; Review and approve executed production batch records, logbooks, and QC Assays; Drive closure/completion (including review and approve) of cGMP documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validation documentation; Author/review/approve quality documents, such as: standard operating procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports; Conduct training on procedures, standard work, safety, and cGMP related topics; Internal and external audit and inspection support as needed; Assist with the implementation and continuous improvement of the Quality System

Requirements

5-7+ years of experience in the pharmaceutical field including 5 years of Quality or Manufacturing experience; Experience in managing multiple, competing priorities in a fast-paced environment; Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations); Previous Quality Assurance oversight experience

Nice to have

BA or BS in a Science or related field or equivalent experience in the Quality function

Benefits

annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, and vision insurance; 401k match; flexible time off; paid holidays including year-end shutdown