Quality Control Investigator - Pharmaceutical

summary:

Responsible for oversight of all laboratory investigations including; OOS, OOT, deviations from procedures, and customer complaints.  Ensures investigations are thorough, with root causes clearly defined, corrective/preventative actions initiated, and any deficiencies identified are addressed during the investigation process.  Also responsible to provide proactive corrections based on trends and assessments to prevent reoccurrences that may lead to or result in test failures. Work with cross-functional department management, QC management, and Analysts as necessary to assign investigations, follow up, and ensure all investigations close in a timely manner.

 NO REMOTE WORK

essential Duties and Responsibilities:

• Responsible for oversight and handling of lab process deviations, Out of Specification (OOS), and Out of Trend (OOT) investigations. This includes investigation assignments, oversight of the investigation process, and final reports.
• Responsible for writing investigation reports as applicable.
• Responsible for OOS/OOT trending, reporting, and CAPA assignments based on deviations and the impact(s) to the product, process, and patient health and safety.
• As part of each investigation gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on a previously manufactured product, as well as the risk to future operations.
• Prepares and analyzes manufacturing and laboratory analytical trend data, and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
• The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
• Provide technical expertise to analysts to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely. This includes all lab testing; i.e. HPLC, GC, data integration, KF, IR, and interpretation of USP tests.
• Updates and maintains all quality management systems, such as TrackWise, in compliance with various governing procedures and policies as they relate to investigations, CAPAs, and trend analysis.
• Works independently to comply with procedure driven guidelines relating to lab investigations and makes decisions that directly affect patient health and safety. 

• Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to subsequent actions for investigations in order to maintain compliance.
• This position requires working with minimal supervision to provide oversight and manage investigations from initiation to completion.  
• Provide lab management and site leadership team with quality KPI's for deviations and CAPA's, assess risks, and escalate issues such as potential Field Alerts when necessary.
• Accountable for the implementation of global quality policy related to deviations.
• Responsible to provide feedback to lab personnel on investigations and CAPA's.
• Ensure events are triaged and initiated in TrackWise within 24 hours.
• Support Nesher's adherence to cGMP regulations by independently monitoring and performing trend analyses for Nesher processes such as lab investigations and CAPA effectiveness to communicate results to the applicable departments and to facilitate proactive process improvement.
• Perform other related duties as assigned to meet departmental and Nesher objectives.

KNOWLEDGE/SKILLS/ABILITIES:

• Strong technical writing skills.
• Demonstrated knowledge of Lab Operations, Quality Control, Quality Assurance, Validation, and pharmaceutical process improvement concepts, and the ability to apply cGMP's.
• Detailed working knowledge of Quality Systems, cGMP regulations, and USP compendia.
• Experience with data integration and interpretation; i.e. Chromeleon, TotalChrom, etc.
• Proven communication skills allowing for the ability to communicate in a clear, concise manner, whether in oral, written or presentation form.
• Strong interpersonal skills to effectively establish and maintain collaborative cross-functional working relationships with all levels throughout the organization and outside business partners.
• Strong organizational and coordination skills to effectively oversee and manage multiple priorities, projects, duties and tasks concurrently.
• Demonstrated ability to work on complex problems and resolve technical issues.
• Demonstrates leadership skills by providing oversight of lab investigation process; including investigation assignments, interviews, follow-ups, process management, and report/TW closure.
• PC proficiency in using Microsoft Office, SAP and TrackWise programs.
• Extensive experience with deviation investigations, CAPA management, effectiveness checks, and training.
• Experience in preparation, management, and follow-up of related FDA inspections.
• Comprehensive knowledge and experience in the application of FDA regulations and guidelines.

EDUCATION/EXPERIENCE:

• Bachelor's degree, preferably in Chemistry, Biology, or Engineering; or the equivalent in pertinent, progressive experience in the pharmaceutical or other highly regulated industry.
• Five (5) years or more of experience in Quality Control and/or Quality Assurance in the pharmaceutical industry (preferred) or other highly regulated industry

 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, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk and hear.
2. Constantly use hands and fingers to operate office machines and equipment.
3. 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.
4. Exert a negligible amount of force continuously and/or up to five 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.
2. Individual is occasionally in proximity to moving mechanical parts and exposure to chemicals.

 Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

1. Eye protection (safety glasses), when accessing areas requiring eye protection.
2. Foot Protection (steel or composite toe safety shoes), when accessing areas requiring foot protection.

Current Openings for Quality Control Investigator Pharmaceutical Jobs at Nesher Pharmaceuticals (USA) LLC