Associate Scientist (Microbiology)

Fresenius Kabi USA; Wilson (NC); On-site; USD 49,000 - 69,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Healthcare benefits

Job summary

Fresenius Kabi USA oversees the implementation of quality plans and assurance regulations across clinical trial processes, revising SOPs and leading adoption of new regulations to ensure GCP standards are met.

Hourly Range: $23.45 - $32.95. Final pay determinations depend on experience, education, knowledge and abilities. Benefits include 401(k), vacation and health coverage.

Qualifications

• Experience with QA in clinical trials.
• Familiar with GCP standards and regulatory requirements.
• Proficient in documentation practices.
• Ability to lead audits and inspections.

Responsibilities

• Be able to articulate work related issues clearly and effectively to management and peers
• Completes testing and documents in compliance with Good Documentation Practices.
• Maintains accurate records of all work performed
• Completes assessment of testing results and recognizes results not meeting acceptance criteria. Promptly reports data discrepancies and out of limits conditions to supervision.
• Carries out documentation, investigation, author incident reports, and conducts corrective actions as assigned.
• Manages work and time based on departmental properties using own judgement and objective reasoning.
• Performs good housekeeping practices
• Follows safety related policies. Makes recommendations.
• Performs peer review of data to ensure compliance and accuracy
• Maintains current training compliance through KabiLift
• Assumes additional responsibilities as assigned

Skills

Quality assurance

GCP compliance

Documentation

Audits

Job description

Job Summary

Oversees the implementation of quality plans and assurance regulations, revises SOPs, supports audits and inspections, and leads the adoption of new regulations to ensure GCP standards are met in clinical trial processes.

Hourly Range: $23.45 - $32.95

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• Be able to articulate work related issues clearly and effectively to management and peers
• Completes testing and documents in compliance with Good Documentation Practices.
• Maintains accurate records of all work performed
• Completes assessment of testing results and recognizes results not meeting acceptance criteria. Promptly reports data discrepancies and out of limits conditions to supervision.
• Carries out documentation, investigation, author incident reports, and conducts corrective actions as assigned.
• Manages work and time based on departmental properties using own judgement and objective reasoning.
• Performs good housekeeping practices
• Follows safety related policies. Makes recommendations.
• Performs peer review of data to ensure compliance and accuracy
• Maintains current training compliance through KabiLift
• Assumes additional responsibilities as assigned

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.