Job Information
Mallinckrodt Pharmaceuticals Analytical Method Validation Specialist in St. Louis, Missouri
Job Title
Analytical Method Validation Specialist
Requisition
JR000014442 Analytical Method Validation Specialist (Open)
Location
St. Louis, MO
Additional Locations
Job Description Summary
The analytical method validation review specialist is responsible for conducing comprehensive reviews of analytical methods to ensure compliance with regulatory standards and are suitable for intended use. This role is critical in maintaining product quality and minimizing risk associated with analytical processes. The scope of responsibility also includes review/improvement/implementation of analytical methods of the St. Louis Plant laboratory systems.
Job Description
ESSENTIAL FUNCTIONS:
Conduct in-depth reviews of analytical method validation protocols, procedures, and associated data.
Assess method performance against established acceptance criteria for parameters such as accuracy, precision, specificity, linearity, range, limit of detection, and limit of quantification.
Evaluate method robustness and ensure compliance with relevant regulatory guidelines (e.g, USP, Ph. Eur., ICH)
Expert in Wet Chemistry analysis with ability to perform wet chemistry and instrumentation analysis on any finished product, raw material, intermediate, in-process or stability sample and demonstrate Subject Matter Expert in Product Line or Proficient in all in Chromatography and Spectroscopy with ability to perform chromatography or spectroscopy analysis on any finished product, raw material, intermediate, in-process or stability sample
Prepare detailed reviewed reports summarizing findings, conclusions, and recommendations.
Participate in closure meetings with stakeholders to discuss review outcomes and gain approval.
Maintain accurate and organized documentation of review activities and findings.
Collaborate with cross-functional teams to address validation -related issues and implement corrective actions.
Stay updated on relevant regulatory requirements and industry best practices.
Independently develop project plans and timelines to achieve desired results with minimal oversight
Regularly uses communication skills to exchange information, including technical, with other departments
Adhere to all safety rules and maintain 100% completion of all safety required training
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Tracking and presenting project related metrics
Participates and leads area projects
Use of analytical balances, HPLC, GC, ICP, KF Titrator, IR, UV, pH Meter, volumetric glassware
Wet testing like assay titrations, colorimetric tests, TLC, heavy metals, and sieves
Able to flex skills to other laboratories based on business need
MINIMUM REQUIREMENTS:
Education:
BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.
Experience:
Minimum of 5 years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance experience. Strong understanding of analytical chemistry principles and techniques. Knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 and Q11 is required.
Preferred Skills/Qualifications:
Excellent written and oral communication skills.
Proficiency in data analysis and interpretation.
Ability to work independently and as part of a team
Understanding of basic statistical principles.
Complete understanding and application of principles, concepts, practices, and standards within discipline.
Knowledge of US and International pharmaceutical manufacturing regulations.
Moderate computer skills and familiarity with Microsoft Office Suite
COMPETENCIES:
Comfort Around Higher Management, Organizational Agility, Customer Focus, Drive for Results, Presentation Skills, Managing through Systems, Written Communication, Decision Quality
ORGANIZATIONAL RELATIONSHIP/SCOPE:
Reports to the Principal Compliance Chemist. Must be self-directed to manage strategic/compliance projects and complaint investigations. Operates independently under limited supervision. Leads technical, cross-functional teams. Plans, schedules, and arranges own and other’s activities in accomplishing objectives. Contacts involve matters of high importance to the organization and includes Customers, Commercial, Manufacturing, Quality, HSE, Engineering, and R&D.
WORKING CONDITIONS:
<30% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds.
40-60% Office environment which includes sitting for long periods of time and computer use.
10-20% Manufacturing environment exposure to temperature, noise, chemical or potent compound exposure.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
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