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PCI Pharma Services · 3 days ago

Clinical Regulatory Affairs Specialist 2

Rockford, IL

Full-time

Onsite

Mid, Senior Level

$70K/yr - $79K/yr

5+ years exp

PCI Pharma Services is a company focused on life-changing therapies and their global impact. The Clinical Regulatory Affairs Specialist 2 is responsible for overseeing company policies related to government regulations, hosting audits, and ensuring compliance with federal regulations while supporting the Regulatory Affairs Manager.

BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical

Responsibilities

Write and implement procedures according to the current Code of Federal Regulations

Assure that company policies are properly followed and applied by all appropriate personnel

Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation

Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports

Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act

Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific

Review and maintain appropriate Site Master Files

Manage and monitor Audit Corrective Actions

Write audit responses pertaining to customer and/or internal observations, and track completion of actions

Review investigations associated with DEA Controlled Products

Submit applicable registration applications

Prepare and present monthly Clinical metrics including Customer specific and overall departmental values

This position may require overtime and/or weekend work

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules

Attendance to work is an essential function of this position

Performs other duties as assigned by Manager/Supervisor

Qualification

Regulatory AffairsAudit ManagementReport WritingControlled Substances KnowledgeComputer SkillsProfessionalismMathematical SkillsProblem SolvingAttention to DetailTeamwork

Required

Bachelor's Degree in a related field and/or 5-10 years related experience and/or training

Basic Mathematical Skills

Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs

Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs

High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms

High Standard of Report Writing