Deviation Specialist

Job Description

Job Description

JOB SUMMARY :

This position thoroughly investigates deviations that arise in various aspects of the company, including Manufacturing, Quality Control and Facilities, using problem solving tools such as root cause analysis to assist with identification of appropriate corrective actions to prevent recurrence. Collaborates with various departments to gather information, evaluate causal factors, and implement appropriate CAPAs, based on root causes identified in deviation. Ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to deviation investigations, deviation initiation, and related CAPA’s. Facilitates cross functional meetings and provides guidance and consultation to the deviation / CAPA process owners and makes recommendations to continuously improve processes.

The Deviation Specialist is a detail oriented, highly organized, and self-motivated individual who is responsible for coordinating investigative activities and writing concise and accurate deviation investigation reports. Additionally, this position will track, trend, and analyze investigation data to identify potential trends and report this information to management / leadership.

The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

1. Thoroughly investigate deviations that are initiated in the Track Wise system including, but not limited to, the following activities :

a. Own and author deviation investigations in a concise and accurate manner, including cross-checking content for accuracy and ensuring information is clear and understandable to a broad audience.

b. Review and assess newly initiated deviations to ensure information entered is complete and accurate and that appropriate immediate actions have been taken and documented. Ensure all potentially impacted products or material is identified in the deviation and placed on hold, when applicable.

c. Perform initial quality impact assessments of new deviations and classify based on potential risk to patient health, safety, product quality and / or regulatory compliance.

d. Ensure any needed interim control measures have been identified and taken to prevent continuation of deviant condition.

e. Collaborate with Subject Matter Experts (SMEs) to ensure adherence to due dates for closure of deviations. Work with SMEs to ensure Extension Requests are initiated, when applicable, to avoid closing a deviation past the assigned due date.

f. Review and approve completed investigation reports. Ensure completed investigations are thorough, accurate and root cause has been clearly identified and supported. Ensure all supporting documentation is attached to the deviation.

g. Ensure any needed CAPAs are initiated and that they align with the identified root causes of the deviation.

h. Perform Final Assessments of completed investigations. Ensure disposition of impacted product has been determined and documented, based on investigation conclusion, and associated corrective actions.

2. Use a root cause analysis approach to evaluate and determine any discrepancy related to personnel, material, equipment, procedure, process, and environmental factors involved or related to the deviation.

3. Gather and attach all supporting evidence during the investigation to include copies of all related documentation and / or data that supports the findings. Also collect photographs, perform personnel interviews, as needed, and view applicable video footage. Ensure that supporting documents are organized, appropriately identified, and that scanned copies are legible.

4. Enter the investigation results in the Track Wise system. Present the investigation report in a clear, concise, and comprehensive manner. Ensure the report is also presented in a logical and sequential order that is easily followed by the target audience / reader and that the root cause has been clearly identified and supported.

5. Identify quality trends through investigations and communicate to management.

EDUCATION AND / OR EXPERIENCE :

Bachelor’s degree preferred but will consider associate degree, or equivalent mix of education and experience, preferably in the pharmaceutical industry.

2 years of experience in a manufacturing / packaging cGMP environment.

KNOWLEDGE, SKILLS & ABILITIES :

• Strong oral communication skills, ability to communicate complex and technical information in written reports in a clear, concise, logical, and sequential manner
• Strong analytical and problem-solving skills
• Attentiveness to details and deadlines with the ability to prioritize work effectively
• Sound understanding of cGMPs and FDA regulations
• Flexibility to operate, and self-driven to excel, in a fast-paced environment
• Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS :

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning : near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands.

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled.