Quality - Laboratory Technician Laboratory Technician
Quality - Laboratory Technician
Job Number: 21-15887
Job Number: 21-15887
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality - Laboratory Technician for our client in Phoenix, AZ.
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!
- The Associate Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing.
- The Associate Analyst is also responsible for peer review and support activities in the laboratory to ensure smooth laboratory operation in accordance with the organizations policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.
- Basic proficiency in MS Word, Outlook, and Excel programs.
- Basic experience with various microbiological testing and environmental monitoring techniques.
- Basic knowledge of electronic laboratory management systems.
- Strong attention to detail.
- Basic organizational skills.
- Basic knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring.
- Basic written and verbal communication skills.
- Ability to gown and maintain a sterile work environment.
- Ability to accurately and completely understand and follow SOP, test method and cGMP requirements; uses good judgement and follows procedures.
- Basic GMP documentation skills.
- Knowledge of laboratory safety practices.
- Ability to pair with mentors for guidance as well as to collaborate with peers on day-to-day tasks; cooperative and works well with a team.
- Willingness to learn and share knowledge.
- Communicates effectively with peers, management and cross-functionally across the site.
- Basic knowledge of laboratory and aseptic processes.
- Ability to work under regular supervision.
- Basic critical reasoning and decision-making skills.
- Ability to pass an initial full physical with annual monitoring.
- Ability to deal appropriately with regulatory agencies during regulatory and non-regulatory inspections.
- Performs routine laboratory and EM activities.
- Prepares schedules and sample labels.
- Performs tests such as (but not limited to) bioburden, Growth Promotion, incoming media/reagent QC, BI testing.
- Operates laboratory equipment used to provide sterile and depyrogenated materials.
- Read EM and testing plates and assess against alert and action levels as appropriate.
- Performs microbial isolation techniques, Gram stains and supports microbial identification process.
- Performs environmental monitoring activities in support of manufacturing.
- Collects utility samples for analysis.
- Maintain qualification status on aseptic gowning, etc.
- Demonstrates aseptic technique when performing a Microbiological Test or EM.
- Perform testing/monitoring activities associated with protocols or special projects as required.
- Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility.
- Communicates appropriately with peers and Laboratory Management regarding scheduled duties.
- Uses tracking tools as appropriate (EM batch release, sample trackers, etc.)
- Administrative tasks.
- Communicate effectively with management regarding more complex issues.
- Participate in departmental training initiatives.
- Document training per procedural and cGMP requirements.
- Actively seeks out opportunities to learn from others within and outside the department.
- Assist other analysts, freely sharing knowledge and experience.
- Executes best practices in the laboratory
- Perform peer review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Ensure all testing is performed in a compliant matter.
- Complete all review in accordance with required timelines.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
- Performs general laboratory duties as assigned.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management.
- High school diploma or equivalent required.
- Bachelors Degree, particularly in Microbiology or Science related field, preferred.
- An equivalent combination of education / experience may substitute.
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:
Jane Bautista | LinkedIn
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.