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Compliance Specialist - Pharmaceutical

Location : Philadelphia PA US 19154
Job Type : Direct
Reference Code : 18741-AB-JC-2
Compensation : 60000.00 - 70000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Compliance Specialist to conduct quality system audits ensuring compliance with SOPs and cGMPs.

  • Perform Out of Specification (OOS) and nonconformance investigations in the analytical chemistry and manufacturing departments.

  • Assist QA department by maintaining and improving cGMP quality Systems.

  • Conduct Internal/external audits and prepare reports of analytical laboratory and manufacturing facilities.  

  • Collaborate with all departments to develop and implement Corrective and Preventive Action (CAPA) plans. Observe and report effectiveness of CAPA plans.

  • Conduct Root Cause Analysis investigations and impact/risk assessments in response to deviations non-conforming events and audit observations  

  • Prepare investigative test plans for non-conforming events.

  • Generate monthly metrics and quarterly trend reports for OOS investigation, non-conforming events and CAPAs.

  • Review change controls for impact and risk assessment

Required Qualifications :

  • BS in Science related discipline

  • Minimum 3 years of experience in pharmaceutical manufacturing or related industry.

  • Experience conducing quality audits in an analytical laboratory or manufacturing environment.

  • Knowledge of cGMPs and FDA regulations related to analytical and pharmaceutical manufacturing practices.

  • Team player with excellent communication and interpersonal skills.

  • Experience with MS office software, including Word, Excel, Outlook.

Contact: Allan Berman

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