The Investigation Specialist will be responsible for initiating, investigating, writing, and participating in investigations associated with QA Operations. The Investigation Specialist will be able to conduct interviews with the Operations and QA support and thoroughly detail findings according to Standard Operating Procedure, to ensure root cause, risk assessment, and corrective and preventative actions are identified and documented within established time frames.

Provide office services by implementing administrative systems, procedures, policies, and monitoring administrative activities for Quality.

• Plan, develop, organize, write and edit Investigations.
• Designs, develops, writes Quality records within a GMP facility Non-Conformances, CAPA, Out of Specifications, Deviations.
• Provide comprehensive support, scientific rationale and support to complete additional testing records related to investigations.
• Utilize investigational techniques such as Root Cause Analysis, 5 Whys, etc. to identify root cause and propose corrective and preventative action.
• Analyzes investigational data to spot trends or deviations within the data that may help provide short term root cause identification leading to long term corrective action implementation.
• Ensure data, content quality, and accuracy of documentation packages. Ensure documentation meets regulatory requirements and complies with all internal Company standards.
• Completes Quality Records within established timeframes.
• Create and maintain ilearn Training System curriculas and trainings working with Managers for proper training assignment for each position specific/job responsibility.
• Perform audits of the Learning Management System per procedure.
• Follow procedures for recordkeeping systems and control of documents to send/request records to storage.
• Support with administrative duties such as travel reservations, hotel, and rental car. Maintain supplies inventory by checking stock to determine inventory level; anticipate needed supplies, place, and expedite orders for supplies, and verify receipt of supplies. Participate in purchase price negotiations.
• Filing of Quality and Training documents.
• Support with Audit and Inspection activities.

Competencies:

• Decision Making
• Strong writing and oral communication, and organizational skills.
• Computer literacy in Microsoft Word, Excel, and PowerPoint
• Ability to work under pressure with multiple tasks and deadlines
• Ability to work independently as well as with key internal and external constituents
• Ability to multi-task and integrate project segments
• Time management skills and the ability to prioritize work
• Data management and Problem-solving
• Ability to analyze data to support investigational testing and conclusions
• Attention to detail and accuracy
• Teamwork, Adaptability, and Confidentiality
• Proven experience working in a technical writing position
• Teamwork, Adaptability, and Confidentiality.

Education / Experience:

Bachelors degree in chemistry or related scientific field requiring a minimum of two years of pharmaceutical industry experience. Excellent technical writing and oral communication skills are required. The individual will also need QA experience in pharmaceutical environment working with raw materials/in-process/finished products/stability. Strong analytical and manufacturing knowledge are required.

Experience/knowledge in the following areas:

• Quality Records within a GMP facility Non-Conformances, CAPA, Out of Specifications, Deviations.
• Pharmaceutical standards and regulations, GMP, GLP, GDP

Excellent written and verbal communication skills; must be organized, motivated and detail-oriented. Ability to interpret complex data sets. Must have ability to work under pressure, overtime, and weekend hours, according to project and/or business deemed necessary.

Work Environment:

Time is spent sitting at desk, operating computer and observing the manufacturing environment / process.

Physical Demands:

Visual acuity and manual dexterity required to operate computer. Majority of the time will be spent writing investigations, deviation reports, CAPAs, etc. Additional requirements involve the ability to stand in the laboratory, gathering information, interviewing analysts on specific details related to the investigation.