Pharmaceutical Quality Assurance and Project Management

Pharmaceutical Staffing Solutions, LLC (A Division of Jeiven Pharmaceutical Consulting, Inc.) is looking for Pharmaceutical Quality Assurance professionals.

 

Candidates must have a minimum of 5-7 years experience in the pharmaceutical industry in a QA/QC role.

 

Responsibilities:

Batch Record Review: Must be experienced in evaluating all documentation to enable release of clinical supplies. QA Monitoring: Must be experienced in observing manufacturing, packaging and labeling activities during execution of client projects at contract facilities.  Must be familiar with US and EU regulations regarding labeling of clinical supplies. Auditing: Must be experienced in conducting quality audits of contract facilities according to GMP standards. Must be able to write clear, concise audit reports which will include observations, recommendations and issues needing resolution.

 

The appropriate candidate will be able to work with minimal supervision and should be able to ?hit the ground running?.  Some travel is required, generally in the Northeast area.

 

Excellent verbal and written language skills are required as is attention to detail.

 

We currently have positions open in Central NJ.  Please indicate your salary requirements.

 

Clinical Supplies Project Manager

 

Candidates must have a minimum of 5-7 years experience in the pharmaceutical industry or contract research organization as a clinical supply project manager.  Responsibilities include the following:

 Manage timelines for manufacturing, packaging and labeling of clinical trial materials.Monitor activities of clinical sites/investigators during the clinical study.Participate in cross-departmental activities for drug development.Perform strategic planning in relation to clinical supply needs in Phase I, II, and III studies.Work effectively with contract research organizations.

 

Minimum of BS degree in pharmacy, chemistry, or biology required. Knowledge of MS Project Management software required.



Assistant Clinical Supplies Project Manager

 

This is a part-time position in Central NJ. The position may become full-time at some point in the future. 

 

Responsibilities:Work with Sr. Project Manager to coordinate projectsFollow-up with contract organizations Monitor project timelines and follow-up with contract organizations

 

Requirements:3-5 years project management experience in a pharmaceutical companyExcellent oral and written communication skillsDetail orientedAdept at follow-upGood organizational skillsKnowledge of Microsoft Project Management softwareBS degree preferred

 

Salary commensurate with experience