Manager, Data Reviewer

GENERAL DESCRIPTION

The Quality Data Reviewer Manager position, under general direction, will be responsible for overseeing the data review of routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory, to ensure compliance with internal procedures and client test methods/protocols/specifications. The Quality Data Reviewer Manager is responsible to ensure activities are reviewed in an efficient and cGMP compliant manner. The Quality Data Reviewer Manager is expected to take initiative, be proactive and lead the data review team. The Quality Data Review Manager will support the Quality Control Laboratory and Quality Assurance (QA) Operation by reviewing/approving analytical data, investigations, deviations, protocols, and analytical test methods to ensure compliance with internal procedures and the quality system.

ESSENTIAL JOB DUTIES

• Workflow management with multiple reviewers by overseeing the day-to-day operation within the data review department.
• Team leadership of the data review team.
• Mentor and train entry level personnel.
• Review and approve of analytical data, laboratory investigations and deviations.
• Review and approve change controls of analytical methods, protocols, and reports.
• Promotes ALCOA+ in documentation, cGMP culture and adheres to the quality system.
• Review time of use logs on cGMP instrumentation and other analytical equipment.
• Review audit trails on computer systems used to acquire and process data from instrumentation (e.g., Empower)
• Ensures compliance of testing with laboratory procedures, test methods and protocols.
• Review/Approve/Reject Drug Product Specifications
• Generate, review, and approve certificate of analyses for release testing or stability testing as applicable
• Work with laboratory personnel to correct any errors and omissions in GMP documentation.
• Engage in continuous improvement activities and adhere to department goals/metrics.
• Participating in audits, cycle audits or client audits as needed.
• Reply to client's questions concerning analytical laboratory data.
• Generate Metrics - (errors by analyst, review category, turnaround times) as needed
• Good Verbal and written communication skills across multiple departments.
• Other duties can be assigned as need it per Director of Quality.

REQUIRED SKILLS/ABILITIES

• Ability to pay attention to detail, focus and multitask on data review.
• Ability to use a computer to accurately to analyze data and generate reports as needed.
• Strong prioritization, organizational skills and detailed oriented.
• Knowledge of various analytical equipment and techniques (e.g liquid and gas chromatography, pH, dissolution).
• Communicate with others clearly and concisely.
• Ability to work in a fast-paced environment
• Proficient in Microsoft Word and Excel.
• Fluency in written English
• Proofreading skills

WORK EXPERIENCE AND REQUIREMENTS

• 5+ years of related experience in pharmaceutical analysis and cGMP regulated industry. Strong analytical background with good documentation practices. Strong Organization Skills.
• Analytical Laboratory experience Required (5+ years)

EDUCATION REQUIREMENTS

• B.S. degree in chemistry or closely related discipline
• M.S. in chemistry or closely related discipline may substitute for work experience

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee will be performing work in multiple buildings on the campus; The frequently is required to stand and walk.; use hands to finger, handle or feel; and reach with hands and arms. The employee will be required to focus on reading/evaluating documents and expected to have great attention to detail.

WORK ENVIRONMENT

Office Environment