Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Location: This role is located onsite (M-F) in Greenville, NC.
Job Summary: A leading pharmaceutical organization is seeking a
Deviation Supervisor to support its quality and compliance operations within a high-volume sterile manufacturing facility. This role will be responsible for the timely completion of investigations. By working cross-functionally between various groups, your team will focus on the identification of root cause(s), trend analysis as well as identification of corrections, corrective actions, and preventative actions (CAPA) to assist in the reduction or elimination of reoccurrence of investigations.
Key Responsibilities:- Leading a team in conducting thorough and structured investigations through data collection, collaboration, and analysis.
- Work on the manufacturing and/or laboratory floor to gather data and observe processes.
- Be a method SME for root cause analysis tools (6M, Fishbone, TapRooT etc.) and general problem-solving techniques.
- Lead, initiate, and assist with the completion of immediate corrections and CAPA items as well as ensuring that CAPA items are robust and pertain to the assignable root causes.
- Ensure that the quality impact to both the patient as well as the product is assessed against applicable regulatory guidelines.
- Escalate activities and barriers associated with investigation planning and completion.
- Write reports and summaries clearly and promptly to ensure timelines are met.
- Compile Key Process Indicators (KPIs) for investigation.
- Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers.
- Be a site champion for projects associated with improvements to investigations.
- Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets).
- Champion a culture of collaboration, flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills.
- Mentor and train staff members.
- Provide oversight of completion of investigations.
- Provide investigation guidance and expertise for complex deviations to all teams on site.
Core Qualities and Competencies:- Be able to prepare information for the educated but uninformed reader and translate complex and scientific events into a readable document.
- Be able to perform statistical analysis when there is a large body of data.
- Strong critical thinking and problem-solving skills by using logic and reason.
- Understand and utilize risk analysis skills.
- Proactively identify area(s) of improvement within a system or process
- Strong communication skills to facilitate meetings to gain internal alignment on root cause(s) and CAPA; may need to be regulatory authority or customer facing.
- Ability to resolve conflict in a cross functional setting.
- Project management and organizational skills to handle and prioritize multiple investigations at one time.
Personality Attributes:- Inquisitive attitude - look past just the obvious solutions.
- Be Unbiased and Analytical - Use objectivity when looking at a problem.
- Structured and Organized.
- Foster Collaboration and Teamwork.
- Strong communication and listening skills.
- Adaptable to embrace change/influence.
- Demonstrate Company Values and have the utmost integrity.
- Demonstrate goal-oriented leadership, driving others to achieve successful outcomes.
Educational and Experience Requirements:- Bachelor's Degree within a Science and/or Engineering discipline.
- A minimum of 5 years in a cGMP environment pharmaceutical, food or cosmetic industry.
- A minimum of 3-year experience in technical or scientific writing principles.
- Demonstrable knowledge of cGMP principles pertaining to investigations and CAPA actions.
- Experience in practical problem solving and continuous improvement projects.
- Experience and proficiency with Track Wise.
- Experience and proficiency with TapRooT or other Root Cause Tools.
- Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint).
- Knowledge of adult learning methodologies; ability to coach and train others.
- Experience with technical writing skills and Root Cause Analysis Tools.
Physical Demands:While performing the duties of this job, the employee is required to walk, sit, and use hands, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as- dust, fumes or odors, temperature extremes, loud noise, strong drafts or bright lights.
Work Environment:This job operates in a professional office environment as well as the Production, Laboratory and Warehouse environment in a pharmaceutical facility. This role routinely involves use of standard office equipment such as computers, phone, photocopiers, filing cabinets and fax machines.
