About us:

Network Partners is a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting that allows our team to work at or with some of the world’s largest and well-known medical device and pharmaceutical companies. It’s the best of both worlds!

Due to tremendous growth, Network Partners is looking for a Quality Investigator to provide guidance and support to our growing professional services team of elite professionals.

Duties:

• The Investigator is responsible to lead, conduct and document investigations relating to non-conformances and/or complaints within a GMP Pharmaceutical packaging organization
• The Investigator will utilize root cause analysis tools, critical thinking and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints
• The Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation
• The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork and influence
• The position will work closely and in collaboration with internal and occasionally external stakeholders
• The Investigator also has responsibilities for data generation, process evaluation and performance metrics for the purposes of customer communication and driving continuous improvement
• The impact of decisions relating to customer interface, investigation conclusions, and documentation supporting recommendations for product impact assessments could expose the company to significant risk or economic loss
• ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Investigator
• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership
• Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types
• Independently lead and/or facilitate floor gembas, cross functional meetings, and operator interviews related to investigations
• Observe processes on shop floor, warehouse, and central support functions (incoming inspection, sales, customer service, project management, validation, and engineering) to ensure investigation is factual and detailed
• Author investigation reports in designated QMS utilizing strong organizational and technical writing skills with demonstrated attention to detail
• Owns data collection and performance metrics relative to the investigation process and CAPA effectiveness and facilitates sharing of investigational findings and risk knowledge through the organization
• Initiates, writes, reviews and assesses change controls and revises SOPs and Work Instructions as needed for action implementation
• Utilizes knowledge, experience, and critical thinking skills to recommend potential product impact outcomes and provides thorough supporting documentation and justification for those outcomes
• Ability to thrive in a dynamic environment, multi-task, and independently prioritize and manage timelines to support packaging schedule, product disposition and release in alignment with organizational and customer goals
• Supports customer relationships related to investigation findings, CAPA implementation and performance metrics and process improvements
• Supports customer and regulatory audits as needed by presenting investigation summary and conclusions in a thoughtful, clear and concise manner
• Lead continuous improvement efforts focused on investigation related processes or the reduction and/or elimination of organizational risk by closing GMP gaps
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs Proactively identify and facilitate resolution of potential risks
• While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor

Top 3 Skillsets- Technical:

• Experience handling investigations for external manufacturing organizations.
• Secondary or primary for solid oral dose packaging experience
• Non-conformances and/or complaints within a GMP Pharmaceutical packaging

Soft Skill:

• Hit the ground running
• Ability to work in fast paced environment
• Communication.
• Lots of work that needs to be done, candidate needs to know that going in and be able to work through some chaos.

Job Type: Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have secondary or primary for solid oral dose packaging experience?
• Do you have experience with non-conformances and/or complaints within a GMP Pharmaceutical Packaging environment?

Experience:

• investigations: 5 years (Preferred)

Ability to Relocate:

• Allentown, PA: Relocate before starting work (Required)

Work Location: In person