Qc Data Reviewer/Lab Manager

The QC Data Reviewer/Lab Manager will report to the Quality Manager and will be responsible for ensuring compliance with Wittman Pharma Quality systems, policies and procedures and in accordance with US and international regulatory agencies, ICH, general cGMP and international guidance. While collaborating with cross- functional departments, this will be a key role in maximizing our technology and progressing our novel therapeutics to the next phases.

Responsibilities

• Review the data to comply with cGMPs, GDP, FDA, and ICH Guidelines
• Data Review of Raw Material, Release and In-Process testing, Stability, Cleaning Verification samples, Microbiological testing, and Analytical test method Development/Qualification/Verification/Transfer/Validation
• Strong prioritization, organizational skills and detailed oriented. Coordinate and discuss with other team members for continuous improvement of the data review process. Discussions and provide suggestions to QC analysts for continuous improvement of the GDP within cGMP requirements and applicable written SOPs, test procedures and methods Ensure completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks.
• Strong technical knowledge of various analytical equipment, techniques, and methodology
• Lead and organize QC Analysts and Lab Technicians as well as interface with managers of other departments as needed.
• Manage the daily operations of the QC Laboratory and perform audits of QC Laboratories on a routine basis and report directly to Quality Manager.
• Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP and to increase efficiency, compliance, and quality
• Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data.
• 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., HPLC, UV-Vis, FTIR, Dissolution, etc.). Ability to use a computer to accurately analyze data and generate reports as needed.
• Assist in writing/reviewing QA events/deviations/Investigation when required.

Qualifications

• Minimum Education: Bachelor’s degree or higher in scientific discipline required
• Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
• Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
• Experience in commercial products is preferred.
• Minimum of 5+ years relevant work experience in Quality Assurance/Data review of QC in a pharmaceutical industry
• Knowledge of Quality Management Systems
• Communicate with others clearly and concisely, ability to work and lead others in a fast-paced environment.
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills
• Experience working with cross-functional teams/sites.
• Ability to effectively train others on programs and procedures.

Language Skills

With a command of the English language, has the ability to read, analyze, and interpret the most complex documents; ability to respond effectively to the most sensitive inquiries or complaints; ability to write using original or innovative techniques or style; ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

To perform this job successfully, an individual should know Spreadsheet and Word Processing software.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this Job, the employee is regularly required to sit, use hands to handle or feel and reach with hands and arms. The employee is frequently required to stand, walk and talk or hear. The employee is occasionally required to climb, balance, stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds. Specific vision abilities required by this job include the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and fumes or airborne particles. The noise level in the work environment is usually moderate.

Job Type: Full-time

Salary: $48,000.00 - $68,000.00 per year

Benefits:

• Professional development assistance
• Life insurance
• Paid time off
• Health insurance
• Dental insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Brooksville, FL 34604: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CGMP: 5 years (Required)

Work Location: In person