Compliance Specialist - Technical Writer
: Job Details :

Business Title: 105064 | Compliance Specialist - Technical WriterIncrease your chances of reaching the interview stage by reading the complete job description and applying promptly.Location: Marietta, PA 17547Job Type: Contract (12+ Months) Job Description:This position will provide quality system compliance for TS (Technical Services) by managing quality system workload, including leading investigations and developing corrective actions, coordinating change controls, creating, and revising SOPs (standard operating procedures) and training records, managing CAPAs, managing departmental self-inspection program, and supporting management of EHS (Environmental Health and Safety) associated tasks owned by TS. Job Responsibilities:Perform root cause analysis which may require facilitation of cross functional teams to investigate deviations and determine robust corrective actions, lead problem solving sessions, and support recurrent and complex deviations using DMAICSupport timely completion of TS quality system action plans - this includes writing, revising, or coordinating the efforts for change controls, SOPs, audits, and training documentationRepresent the TS department at the site change control meetingsPrepare and track change controls to make improvements outside of deviationsInclude assessment of Global QMS (Quality Management System), Engineering, and EHS standards in creation and revision of TS SOPs to align with global requirements and requestsTrack, trend, and evaluate TS misalignments and work to determine root causes - this includes tracking and trending progress of CAPA's (EHS and GMP) using a routine reporting systemInteract and coordinate with appropriate personnel including manufacturing, Supply Chain, TS, QA/QC, regulatory, etc.Communicate immediately with QA, Operations, Supply Chain, and EHS management for all TS discrepancies that impact product quality or safetyDevelop internal GMP and EHS audit schedules (including area to be audited) on a yearly basisInteract with external regulatory authorities as needed during routine and non-routine auditsPerform all job responsibilities in compliance with the company safety procedures and all applicable EHS regulations, SOP's, and industry practicesMonitor process health through various governances, scorecards, data trending, etc. and problem solve or escalate issues when out of acceptable state Skills & Experience Required:B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy3+ years of pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing roleWorking knowledge of pharmaceutical facilities, equipment, and systems - including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activitiesKnowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and complianceDemonstrated problem solving and investigational skills