Career CategoryQuality
Job DescriptionSR. ASSOCIATE QUALITY CONTROL IWhat you will doLet's do this. Let's change the world. In this vital role you will perform routine Microbiological testing and provide technical support for Environmental Monitoring and Utilities Monitoring programs, working at a Drug Substance manufacturing facility. The Senior Associate, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology.
- Perform routine microbiological testing, including but not limited to endotoxin, bioburden, TOC, conductivity, and microbial identifications.
- Support sample type validation testing for microbiological assays as needed.
- Perform data review for activities performed within the Microbiology department.
- Assist EM and Utilities Program owners in tracking and trending excursions, notifying key stakeholders, and assessing remediation activities.
- Support cross functional investigations relating to EM and Utilities excursions representing the microbiology department and assist with coordinating re-sampling activities when required.
- Act as coach and mentor for junior staff and perform training for microbiological techniques and assays.
- Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
- Own, manage, and participate in continuous improvement initiatives within the QC organization.
- Represent Amgen North Carolina while participating in network forums relating to microbiological testing, Environmental monitoring, and Utilities Monitoring.
- Perform routine laboratory tasks such as cleaning and inventory management.
- Author, revise, and review documents and reports including but not limited to: SOPs, protocols, safety assessments, methods, trend reports, qualification/validation summary reports, microorganism assessments, technical reports, and method assessments.
- Own, manage, and participate in laboratory investigations, deviations, and CAPAs.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is an experienced quality control analyst with these qualifications.
Basic Qualifications:- High school/GED + 4 years of related GxP laboratory work experience OR
- Associate's + 2 years of related GxP laboratory work experience OR
- Bachelor's + 6 months of related GxP laboratory work experience OR
- Master's
Preferred Qualifications:- Related experience in the pharmaceutical industry, preferrable working in a GxP Microbiology lab, or supporting GMP manufacturing operations.
- Degree in Microbiology, Biology, Biochemistry, or related scientific field.
- Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, and Environmental monitoring.
- Strong knowledge of aseptic technique.
- Strong written and verbal communication skills, including technical writing and technical presentations.
- Maintains a thorough understanding of GxP Regulations and industry standards.
- Able to flexibly work independently, as a project owner/manager, collaboratively on group tasks, and as a trainer.
- Experience owning, managing, and participating in deviations, CAPAs, and cross functional investigations.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range78,724.45USD -106,509.55 USD
