Lead Quality Specialist - Investigator

Job Description

Job Description

Job Summary -

Serves as the OOS/OOT/NOE and other investigations Lead Quality Specialist-Investigator in the Quality Control department. Responsible for leading/completing/closing laboratory investigations and any required analytical reports. Interacts frequently with site departmental leaders to provide perspective on investigation progress, impact, root cause analyses and timing of investigation closure. Works collaboratively with QC/QA/Manufacturing for identification of CAPAs, any document updates and timely closure of investigations

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Provides investigative support for the QC Laboratory.

Key Accountabilities / Responsibilities -

Initiation, Execution, Closure of QC Lab Investigations

• Initiates and conducts OOS/OOT/NOE investigations with timelines driven by procedures
• Provides timely support and direction to the QC team during investigation execution, opening, writing and closing QC Lab investigations.
• Interviews personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
• Uses laboratory software for root cause and impact analyses of data
• Maintains awareness to the needs of the QC laboratory department and other departments in order to meet scheduling needs.
• Performs root cause analyses and impact analyses during investigation workflow to determine true cause.
• Interacts frequently with Departmental leaders to provide perspective on timing of controlled document needs such as
• Conducts quality control laboratory walkthroughs and notes any compliance issues and reports to management.
• Experience speaking and interacting with Cross Functional Team QC, QA and site management

CAPAs

• Proactively work with team members to identify and implement effective corrective and preventive actions (CAPAs) and to ensure the timely completion of CAPAs within the laboratories.
• Assist with training, procedure and monograph updates, as needed based on investigation outcome.
• Works collaboratively with QA, RA and other site departments for revisions to laboratory records, as needed.
• Provides recommendations for the improvement of processes by working cross-functionally with multiple collaborators.
• Implements corrective actions that contribute to a Continuous Improvement process

Compliance

• Identifies compliance risks to management, provides remediation proposals, and leads solution implementation for issues.
• Provide compliance support, expertise and training for all impacted departments.

Qualifications

Education & Experience

• BS degree in Chemistry, Biology or Pharmaceutical Sciences.
• Minimum of 4 years’ experience in a pharmaceutical manufacturing environment

Knowledge

• Understands chromatography (HPLC and GC) and has detailed knowledge of HPLC test methods and related equipment
• Working knowledge of Chromatographic Data System (Empower preferred) and applications including Trackwise, etc.
• Experienced and knowledgeable in QC lab testing
• Well versed in data review and data integrity
• Technical and quality background related to pharmaceuticals
• Basic knowledge of Compendia (e.g., USP, EP, JP, etc.) requirements and standards
• Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines

Skills & Abilities

• Strong Technical Writing skills.
• Established problem-solving and decision-making skills.Strong communication skills with peers, chemists and senior management.
• Critical Thinker, seeks to understand and resolve issues
• Strong focus on quality and proven ability to apply a high degree of integrity.
• Customer/Stakeholder focused (understand business plans and operating environment).
• Demonstrated skills in investigation execution, root cause and impact analyses

Physical Requirements

• Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.
• Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
• Ability to wear personal protective equipment, including respirators, gloves, etc.
• Specific visions abilities are required by this job include close vision and color vision