Compliance Specialist - Technical Writer
The Accuro Group
Marietta, PA
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JOB DETAILS
SALARY
$65–$70 Per Hour
JOB TYPE
Temporary, Contractor, Full-time
SKILLS
Auditing, Biochemistry, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Drug Manufacturing, Environmental Health, FDA Requirements, GMP (Good Manufacturing Practices), Manufacturing, Microbiology, National Institutes of Health (NIH), Pharmacy, Problem Solving Skills, Product Safety, Quality Assurance, Quality Control, Quality Management, Records Management, Regulations, Regulatory Requirements, Root Cause Analysis, Safety Compliance, Safety Process, Safety/Work Safety, Scorecarding, Six Sigma DMAIC, Standard Operating Procedures (SOP), Standards Development, Supply Chain, Supply Chain Management, Supply Chain Operations, Systems Administration/Management, Technical Services Management, Technical Writing, Time Management, Trend Analysis, Virology
ADDITIONAL COMPENSATION
only w2.
LOCATION
Marietta, PA
POSTED
19 days ago
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
About the Company
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The Accuro Group
Accuro connects talented financial, professional and technical contributors with the world’s best companies.
Whether you’re interested in rewarding consulting engagements—or advancing your career with a leading organization—Accuro is here to help you navigate this journey.
For more information, visit us online at accurogroup.com
COMPANY SIZE
50 to 99 employees INDUSTRY
Staffing/Employment Agencies
FOUNDED
2003
WEBSITE
http://accurogroup.com/