Quality Control Scientist (Microbiology) I/II/II/Sr.

Bachem; Vista (CA); In loco; USD 41.000 - 99.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Descrizione del lavoro

Bachem Americas is seeking a Quality Control Scientist (Microbiology) to lead the environmental monitoring program, water and critical utilities testing, and GMP documentation. The role involves trend analysis, endotoxin testing, and maintaining cleanroom and QA processes in a highly regulated biopharmaceutical environment.

The candidate will write SOPs, support calibration and instrument maintenance, and collaborate with cross-functional teams to ensure regulatory compliance, data integrity,

Descrizione del lavoro

A Brief OverviewThe Quality Control Scientist (Microbiology) will manage and execute the environmental monitoring program, water and critical utilities monitoring program. Other duties include performing, QC documentation including lab notebooks and reports and related GMP activities.

A Brief OverviewThe Quality Control Scientist (Microbiology) will manage and execute the environmental monitoring program, water and critical utilities monitoring program. Other duties include performing, QC documentation including lab notebooks and reports and related GMP activities.

What You Will Do

• Perform necessary environmental monitoring procedures to include water sampling, viable and non-viable air sampling and viable surface monitoring
• General upkeep of microbiology laboratory including monitoring of temperatures for incubators and storage refrigerators
• Perform necessary testing for approval of vendors and qualification of necessary media used in the microbiology laboratory
• Maintain and support the cleaning verification program by performing Total Organic Carbon testing
• Trend microbiology data and report to management and QA to ensure systems are within trend
• Perform endotoxin testing for final lyophilized peptide products. The kinetic and gel clot method will both be employed
• Write/revise standard operating procedures, and other related GMP documentation as related to the job function as necessary
• Maintain GMP areas to ensure compliance for all requirements for control of materials. This includes cleanliness and organization
• Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
• Operate, maintain and ensure calibration of equipment including, chart recorders, thermometers, analytical balance, pipette and other related equipment in microbiology lab and the GMP facility as required by job function
• Investigate any deviation or out of specification as necessary related to Quality Control work performed as instructed by supervisor
• Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste

Qualifications

• Bachelor's degree in chemistry, microbiology or related field
• Master's degree in chemistry, microbiology or related field (preferred)
• Minimum of 3 years’ experience in the pharmaceutical, biotechnology, or related life sciences industry
• Strong hands-on experience with microbiological and analytical techniques/instruments including but not limited to: Total Organic Carbon (TOC),Endotoxin (LAL), Conductivity, Bioburden testing, and Microbial Identification (e.g., MALDI-TOF).
• Proficiency in environmental monitoring (EM), cleanroom qualification, and data trending programs using tools such as MODA, LIMS, or equivalent.
• In-depth understanding of ICH guidelines (Q1, Q5, Q7, Q9, Q10), USP , , , , and current FDA, EMA, and global regulatory expectations.
• Experience working in classified cleanroom environments (ISO 7 and ISO 8) and aseptic processing operations.
• Familiarity with quality risk management, deviation/investigation processes (e.g., CAPA), and root cause analysis tools (e.g., Fishbone, 5 Whys).
• Strong documentation practices in compliance with ALCOA+ principles and data integrity standards.
• Ability to plan, organize, and prioritize multiple tasks while working independently or as part of a cross-functional team.
• Demonstrated ability to communicate clearly and effectively across technical and non-technical teams, including presentation of findings to internal stakeholders and external regulators.
• Proficient in Microsoft Office Suite, with added benefit of experience in electronic quality systems (e.g., TrackWise, MasterControl).
• Willingness to work flexible hours, including occasional night shifts and weekends, based on operational needs.

Base Hourly Range:

• Scientist I: $30.01 - $45.02
• Scientist II: $34.70 - $52.05
• Scientist III: $41,81 - $62.72
• Sr. Scientist: $48.08 - $72.12

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you'll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation - regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.