Analytical Data Integrity Supervisor

Within the Analytical Services Department, the Analytical Data Integrity Supervisor role is for a subject matter expert and experienced leader with responsibility to lead a flexible team of 5 to 10 junior and senior laboratory personnel tasked with data and documentation review, quality investigations, and data compliance in support of Ritedose’s internal ophthalmic, pulmonary, and parenteral products, as well as, Ritedose’s CDMO operation.

Responsibilities:

• Develop and lead an effective analytical group within the Analytical Services Department tasked with data and documentation review, quality investigations, and data compliance.
• Develop and communicate deviation trending metrics and coordinate with laboratory leadership to devise strategies to reduce laboratory deviations and repeat testing by identification and remediation of deficiencies in testing methodology, laboratory equipment, and / or personnel training.
• Oversee the data integrity and compliance review or laboratory documentation, including batch records, stability data packets, raw material testing results, developmental reports, lab notebooks, other quality documents, and procedures.
• Coordinate with other Laboratory Services Managers/Supervisors for the efficient use of laboratory personnel resources.
• Responsible for training oversight of staff.  
• Functions as a technical expert regarding analytical methodology and data compliance for product testing in the laboratory.
• Coordinates with the Quality Assurance and Stability groups for disposition of tested product.
• Functions as a usage expert for Ritedose’s LIMS system.
• Lead/complete laboratory Out-Of-Specification and Out of Trend investigations  
• Assist in the generation and tracking of laboratory testing metrics and budgeting.
• Plan capital budget and procure laboratory instruments as needed
• Lead regulatory audits as assigned.
• Provide technical support to the quality control team to address method and testing challenges.

• Responsible for maintaining subject matter expertise with the latest industry standards, for example FDA and ICH guidance for method lifecycle management, Out-Of-Specification guidelines, and data integrity.
• Lead in the creation and collaboration of laboratory documents as assigned.
• Adhere to Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines.

Qualifications:

• BS degree in Chemistry or related field with a minimum 10 years of experience, or a MS degree in Chemistry or related field with a minimum 8 years of experience, or a PhD in Chemistry with a minimum 5 years of experience, in a pharmaceutical laboratory environment required
• Minimum 2 years leadership experience in a laboratory environment
• Ability to effectively manage both junior and senior level scientists to meet the goals of the group
• Subject Matter Expertise with laboratory techniques used in the routine testing of TRC products, e.g., wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required
• Strong documentation skills and proficiency with current word processing, spreadsheets, and database software required
• Ability to lead laboratory investigations and focus on a true root cause analy