Compliance Specialist - Technical Writer at The Accuro Group

Business Title: 105364 | Compliance Specialist - Technical Writer
Location: Marietta, PA 17547
Job 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 DMAIC
• Support timely completion of TS quality system action plans - this includes writing, revising, or coordinating the efforts for change controls, SOPs, audits, and training documentation
• Represent the TS department at the site change control meetings
• Prepare and track change controls to make improvements outside of deviations
• Include assessment of Global QMS (Quality Management System), Engineering, and EHS standards in creation and revision of TS SOPs to align with global requirements and requests
• Track, 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 system
• Interact 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 safety
• Develop internal GMP and EHS audit schedules (including area to be audited) on a yearly basis
• Interact with external regulatory authorities as needed during routine and non-routine audits
• Perform all job responsibilities in compliance with the company safety procedures and all applicable EHS regulations, SOP's, and industry practices
• Monitor 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 Pharmacy
• 3+ years of pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role
• Working 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 activities
• Knowledge of GMP’s, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance
• Demonstrated problem solving and investigational skills