Job Description

Job Description: 

The duration for this role is 6 months

Responsibilities Include:

• CAPA/Deviation Investigation Closure. 
• QA Investigations
• Compliance investigator to perform investigations on manufacturing deviations. 
• Conduct and write-up deviations investigations in a pharmaceutical facility.
• Responsible for the resolution of deviations, CAPAs, or other documents in order to meet production and product release requirements.
• Utilize root cause analysis techniques during deviation investigational process.
• Work cross-functionally, to support the development and implementation of continuous process improvements
• Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
• Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress

Qualifications

Qualifications:

• BS/MS in science major or extensive equivalent experience
• Written investigation experience
• CAPA experience
• Preferred experience with filling operations, solution prep, and fill/finish/formulation
• General knowledge of quality system elements and cGMP regulations.
• Good knowledge of Quality Assurance / Compliance, FDA 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
• Proficient in Microsoft Word, Excel, PowerPoint and Project.
• Must be willing to travel regionally and/or nationally throughout the US.

Additional Information

All candidates must be legally eligible to work in the USA.

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