Sr. Quality Control Analyst (Pharma)

Shift:

Monday through Friday, 8:00AM - 5:00PM

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

SUMMARY

Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and qualify analytical methodologies for small molecules and biologics for early-stage clinical trials. May interpret analytical data to guide formulation and process development decisions.

Compensation: $90,000.00 - 110,000.00 per year

ESSENTIAL FUNCTIONS

• Serves as a lead to staff to include providing work direction, guidance, and training.
• Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information.
• Provides proper documentation of practices following GxP and QC procedures.
• Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
• Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Provides training and guidance on analytical tests, methods, and instrumentation, as required.
• Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
• Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
• Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
• Develop validate and transfer analytical methods. Provide routine and non-routine analysis using analytical techniques such as HPLC, ddPCR, ELISA, and various bioassays.
• Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials.
• Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
• Develops critical material qualification protocols and maintains up-to-date inventory of critical materials.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry/biochemistry, or a closely related field.
• 5-8 years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred.

Required Knowledge and Skills

Required Knowledge

• Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development.
• Broad understanding of the administration and oversight of chemistry/biochemistry progr