Quality Control Analyst

The Quality Control Analyst will support method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes. The candidate must be able to Interpret data, troubleshoots, assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. The candidate will ensure maintenance and calibration of laboratory equipment and systems, support cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures as required.

This is a 12-month contract based in Hillsborough, Oregon.

Responsibilities

• Responsibilities include implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and policies, plans, objectives and procedures.
• Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.
• Impacts quality of own work and the work of others on the team; works within guidelines and policies.
• Maintain a state of inspection readiness.
• Works autonomously with guidance only on complex new assignments.
• Uses ability as a technical/functional expert to contribute in development of concepts and techniques, and to complete complex assignments in creative and effective ways.
• Perform environmental monitoring and water sampling.
• Has interaction at the Supervisor and Manager levels on matters pertaining to the immediate area of work. Interactions require tact and effective communication skills as they often involve complex and sensitive information.
• Participate in the design and implementation of department and cross-functional initiatives.
• Apply basic theory and technical principles to address moderately complex problems.
• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Perform any other tasks as requested by Management to support Quality oversight activities

Qualifications

• B.A. or B.S. degree (preferably in Life Science) and at minimum 3 years’ experience in a cGMP pharmaceutical industry.
• Hands-on industrial laboratory experience with aseptic sampling and testing techniques.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
• Routinely exercises sound judgment, reasoning and problem solving.
• Capable of working under moderate supervision and determining own short-term priorities.
• Work Environment/Physical Demands/Safety Considerations: Work in office and laboratory environment. Lift up to 25lbs may be required.
• Ability to sit, stand and move within workspace for extended periods.
• May be required to sit at a computer terminal for extended periods.
• Strong verbal and written communication skills, ability to organize and present information in a formal and informal group setting.

Salary

• $70,179-$87,734

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.