Operations Compliance Specialist

Summary

Technical leader of deviation investigations, event risk and impact assessments, root cause analysis, corrective and preventive actions to mitigate potential repeat of events and to ensure the continuation of GMP compliant operations. Technical writer of events related to Operations and Quality Assurance processes, equipment and systems. Gather information from all necessary sources in order to evaluate the impact of deviations on manufactured product, as well as the risk to future operations. Conduct and write formal investigation reports. Responsible to ensure timely investigations and CAPAs are being performed and implemented with proper documented evidence, while working closely with associates at multiple levels within the organization.  Perform trend analysis to evaluate CAPA effectiveness and to understand and sustain equipment, processes and systems in a state of control and compliance.

Essential Duties and Responsibilities

• Lead events investigations related to operations and quality processes, equipment, systems and product.
• Lead multifunctional teams related to events investigations to determine root cause, ensure adequate scope, and establish effective corrective and preventive actions.
• Author investigation reports and risk and impact assessments.
• Assist with the implementation of corrective and preventive actions when necessary.
• Track and trend CAPAs for effectiveness verifications.
• Author, execute and write final summary reports for operations and quality investigation protocols.
• Outline and implement process improvements to proactively prevent quality events, increase quality, efficiency, and compliance.
• Assist Operations and Quality in improving process, systems and equipment capabilities and implementing performance metrics.
• Assist Operations and Quality with technical troubleshooting and problem solving.
• Track and provide appropriate updates on status. Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.
• Work independently to complete investigations and CAPAs in alignment with established procedures and timelines.
• Work across functions with a professional manner to conduct investigations.
• Assist in writing, reviewing and revising standard operating procedures (SOPs) and batch manufacturing records to reflect current processes, when necessary.
• Support FDA audits and other regulatory inspections.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices, FDA, DEA and other legislation regulating the production operation.
• PC proficiency using Microsoft Office required; MiniTab and Trackwise a plus.
• Proven organizational and time management skills with ability to effectively manage multiple priorities in a fast paced, dynamic environment.
• Strong oral and written communication skills (with an emphasis on technical writing), with ability to be clear and succinct in a variety of communication settings and styles; to include reports, technical documents, and presentations.
• Proven interpersonal skills to effectively influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
• Ability to think critically and apply critical thinking processes to investigations, CAPAs, auditing, and data reviews.
• Demonstrated ability to read, comprehend, interpret, enforce and apply written technical procedures, current Good Manufacturing Practices, and Standard Operating Procedures (SOPs); with ability to revise SOPs as needed.
• Advanced organizational skills to complete multiple activities and projects on time and within defined scope/requirements.

EDUCATION/EXPERIENCE

• Bachelor's degree in in the sciences or related technical field.
• Minimum three years' experience in a role that involves conducting investigations; CAPA processes; coordinating and implementing process and systems quality; efficiency and compliance improvements; gathering and trending process and systems performance data, and/or other related functions in a pharmaceutical or other highly regulated environment such as medical devices. Experience and technical knowledge in solid dose manufacturing is preferred.
• Experience in using statistical software such as MiniTab or Stat Graphics for root cause analysis, trending and problem solving.
• Six Sigma training or certifications and comprehensive knowledge of the DMAIC process for problem solving are highly desirable.
• A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.

Work Environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, reach, talk, and hear.

2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Normal office conditions.

1. Occasionally in a proximity to moving mechanical parts, laboratory equipment and exposure to chemicals.
2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

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

Current Openings for Operations Compliance Specialist Jobs at Nesher Pharmaceuticals (USA) LLC