GENERAL DESCRIPTION OF POSITION

The primary responsibility of this position is to analyze drug substances, drug products, and/or stability samples using approved laboratory monographs/specifications, Standard Operating Procedures, and USP/NF methodologies to ensure drug products manufactured at and distributed by Pharmaceutical Associates, Inc. meet all quality and compliance requirements.

TECHNICAL

• cGMP/GDP awareness and compliance
• Maintains lab housekeeping and cleans glassware
• Performs basic wet chemistry analysis including:
  • Titrations
  • Identification tests
  • Impurity analysis
  • Residual solvents
• Provides in-process and final sample testing in support of production
• Familiar with compliance methodologies:
  • Lab monographs / specifications
  • Standard Operating Procedures (SOPs)
  • USP/NF
• Familiar with use of chromatographic instruments:
  • HPLC
  • GC
• Executes OOS investigation plans
• Performs tech transfers

COMMUNICATION & COLLABORATION

• Collaborates with key stakeholders within the department to meet shared goals and/or timelines
• ses the appropriate form(s) of communication (both method and tools), considering the recipient of the information and the intended audience

LEADERSHIP

• May train employees as appropriate on fundamental knowledge, laboratory procedures, analytical test methods and instrumentation
• May direct the work of technicians and/or temporary employees

WORK ETHIC & PROFESSIONALISM

• Ensures that tasks performed are consistent with Company Policies
• Demonstrated behavior is professional and consistent with corporate values
• Completes work related to project or program objectives in a timely, organized manner
• Readily admits mistakes and offers solutions to ensure compliance
• Maintains a clean and safe working environment
• Designs a series of tasks with the appropriate use of company resources in mind

GROWTH & INNOVATION

• Displays tactical thinking and reasoning in completing assigned tasks
• Demonstrates openness to new technologies, new processes and new practices
• Makes recommendations for continuous improvement projects that improve the effectiveness of department methods, processes, and equipment
• Uses problem-solving and decision-making skills to impact projects

EDUCATION / EXPERIENCE

BS in Science + 2 years' experience

ADDITIONAL INFORMATION

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily.

PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled