Packaging Gap Assessment QA Consultant - Allentown, PA

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Our client in Allentown, PA is getting certified to go fully commercial in packaging and has recognized a need to bring in an outside QA Consultant to perform a gap assessment against their documentation to determine whether or not they are prepared to fully distribute and package while remaining FDA compliant. Primary packaging products are solide dose, blistering and bottling. Position will be primarily remote, with 1-2 short term trips needed. Duties include, but are not limited to:

• Review current procedures and policies and assess if they are in-line with operational packaging facilities.
• Create a findings report and provide recommendations of remedial activity, documentation update and/or process improvement.
• Go on-site to discuss with leadership and how these changes will be rolled out.  This could lead to a contract extension if it's decided upon that they want the consultant to oversee roll-out.  

• Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 5 plus years related industry experience.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• General knowledge of quality system elements and cGMP regulations.
• Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
• Ability to write and revise Standard Operating Procedures.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
• Carry out duties and responsibilities with limited supervision.
• Flexibility to work occasional weekends and evenings.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
• Ability to plan and manage own work
• Must be willing to travel regionally and/or nationally throughout the US.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***