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