Job Number: 21-14053
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Analyst for our client in Carlsbad, CA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- You will help your direct manager to manage the comprehensive quality activities within Microbiology Lab, including managing tracking and trending Microbiology testing data, managing timelines while ensuring the production environment is in a state of readiness for both testing, client audits, and regulatory inspections.
- The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.
- You will support the daily operations of the Microbiology Lab and other functional groups.
- You will need to manage and track the completion of the testing documentation, data entry, data review, and trending for Microbiology data in a timely manner.
- Responsible for performing a wide variety of microbiological testing methods, but not limited to raw material testing, raw material qualification and water testing as needed.
- Proficient in performing, analyzing, and reviewing water sampling/testing, sterilization of equipment, growth promotion, endotoxin, microbial identification, biological indicator, and bioburden testing data.
- Able to write and execute Bioburden Method Validation protocol, not limited to LAL Method Verification protocol.
- Demonstrate proficiency in the software usage, data analysis and interpretation of testing data and trends.
- Ensure that all of the required electronic data and documentation (raw data, testing records, and logbooks) are completed, reviewed, trended accurately, and entered in a timely manner.
- Drive the testing data entries, tracking, and trending to completion.
- Proficient in initiating, investigating, resolving, and completing event records in accordance with Client TrackWise.
- Key personnel for reviewing and trending Microbial Identification data and its completion.
- Operates and maintains lab equipment as required by SOPs and testing procedures
- Actively support SOP revision processes, Item Specification, and other related documentation.
- Proficient in leading protocol and special study executions.
- Proficient in protocol and final report writing for special studies and projects.
- Participate in scheduling team's weekly schedule and managing group meeting in the absence of Microbiology Management.
- Acts as an SME for the junior analysts in routine and non-routine tasks.
- Able to complete work independently and efficiently based on current SOPs, study protocol, regulatory guidance and industry practice with no supervision.
- Able to distinguish potential issues and professionally suggest potential solutions based on quality system guidelines and regulatory guidance.
- Proactively assess current test method, current practice, and suggest process improvements to ensure regulatory guidance area followed and compliance area met.
- Prioritize tasks to ensure that projects are completed by the assigned deadlines.
- Support team building by participating in interviewing new talent.
- Comply with company EH&S requirements. Promote a safety-first culture.
- BS degree or higher in a Life Science discipline or equivalent.
- BA/BS in scientific discipline with 3 or more years of relevant experience
- High School Diploma or Associate Degree in a Life Science discipline plus a minimum of 4-5 year of relevant experience.
- Previous experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, and electronic software is a must. Previous knowledge/experience with automation, troubleshooting for machineries, equipment, and data integrity is a plus.
- Strong understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals is a plus.
- Previous understanding with Aseptic Technique is a must. Previous knowledge/experience with Aseptic Gowning is a plus.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.