Davita Inc.
Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Responsible for the day-to-day operations of the QC Microbiology laboratory, including overseeing environmental monitoring of classified spaces and routine testing of USP-controlled utility systems and microbiological assays of in-process samples and finished products. Ensure timely testing and release of all samples. Relies on experience, analytical skills, and knowledge to make judgments to accomplish goals. Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties include but are not limited to: Supervise lab personnel and oversee work schedules. Mentor and develop staff to meet technical and business needs. Perform trending and data analysis with statistical evaluation of environmental monitoring and utility data, and write quarterly reports. Investigate Environmental Monitoring excursions and incidents during aseptic filling and routine monitoring. Conduct risk assessments and investigations with CAPAs. Collaborate with Operations and Facilities to maintain process sterility and aseptic conditions. Identify microbial contaminants and isolates. Oversee endotoxin, bioburden testing, growth promotion of media, environmental monitoring, and utilities testing. Support validation, calibration, and maintenance of microbiological equipment. Maintain relationships across sites, organizations, and clients. Ensure cGMP compliance and timely delivery of quality results. Write and review SOPs and coordinate method development and validation. Guide personnel to ensure test results and procedures comply with regulatory standards. Special Demands:
The physical demands are representative of those needed to perform the essential functions of this job. The employee must be physically capable to perform duties with or without reasonable accommodations. Self-motivated with a drive for excellence; capable of inspiring staff. Positive attitude and interpersonal skills. Honesty, integrity, respect, and courtesy. Ability to work in a complex environment with competing demands. Deal effectively with ambiguity. Excellent organizational skills. Strong communication skills. Proficient in statistical and data analysis. Ability to multitask. Deep knowledge of US, EU, and international environmental monitoring regulations. Work Environment:
The work environment includes working at all NH PCI sites, including remote locations, gowning in ISO environments, lifting up to 20 lbs., supporting off-shift activities, managing staff responsibilities, and traveling as needed. Must be able to work at all sites, including remote locations. Ability to gown and work in ISO environments. Lift to 20 lbs. Support off-shift activities occasionally. Qualifications:
The following are required or preferred: Master's Degree in Microbiology, Biology, or similar with 3-5 years' GMP QC experience; or Bachelor's Degree with over 5 years' experience. Leadership experience in GMP QC Microbiology for 1-3 years. Experience in aseptic manufacturing preferred. #LI-LL1 Join us and be part of building the bridge between life-changing therapies and patients. Let's talk future. Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, age, sex, creed, national origin, and other protected statuses. At PCI, Equity and Inclusion are core to our purpose: Together, delivering life-changing therapies. We are committed to an inclusive workplace, fostering understanding, fairness, respect, and equal opportunity at every level. We envision a community where everyone can belong and grow, and we strive to realize this through our practices, policies, and culture.
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We are PCI.
Our investment is in People who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Responsible for the day-to-day operations of the QC Microbiology laboratory, including overseeing environmental monitoring of classified spaces and routine testing of USP-controlled utility systems and microbiological assays of in-process samples and finished products. Ensure timely testing and release of all samples. Relies on experience, analytical skills, and knowledge to make judgments to accomplish goals. Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The duties include but are not limited to: Supervise lab personnel and oversee work schedules. Mentor and develop staff to meet technical and business needs. Perform trending and data analysis with statistical evaluation of environmental monitoring and utility data, and write quarterly reports. Investigate Environmental Monitoring excursions and incidents during aseptic filling and routine monitoring. Conduct risk assessments and investigations with CAPAs. Collaborate with Operations and Facilities to maintain process sterility and aseptic conditions. Identify microbial contaminants and isolates. Oversee endotoxin, bioburden testing, growth promotion of media, environmental monitoring, and utilities testing. Support validation, calibration, and maintenance of microbiological equipment. Maintain relationships across sites, organizations, and clients. Ensure cGMP compliance and timely delivery of quality results. Write and review SOPs and coordinate method development and validation. Guide personnel to ensure test results and procedures comply with regulatory standards. Special Demands:
The physical demands are representative of those needed to perform the essential functions of this job. The employee must be physically capable to perform duties with or without reasonable accommodations. Self-motivated with a drive for excellence; capable of inspiring staff. Positive attitude and interpersonal skills. Honesty, integrity, respect, and courtesy. Ability to work in a complex environment with competing demands. Deal effectively with ambiguity. Excellent organizational skills. Strong communication skills. Proficient in statistical and data analysis. Ability to multitask. Deep knowledge of US, EU, and international environmental monitoring regulations. Work Environment:
The work environment includes working at all NH PCI sites, including remote locations, gowning in ISO environments, lifting up to 20 lbs., supporting off-shift activities, managing staff responsibilities, and traveling as needed. Must be able to work at all sites, including remote locations. Ability to gown and work in ISO environments. Lift to 20 lbs. Support off-shift activities occasionally. Qualifications:
The following are required or preferred: Master's Degree in Microbiology, Biology, or similar with 3-5 years' GMP QC experience; or Bachelor's Degree with over 5 years' experience. Leadership experience in GMP QC Microbiology for 1-3 years. Experience in aseptic manufacturing preferred. #LI-LL1 Join us and be part of building the bridge between life-changing therapies and patients. Let's talk future. Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, age, sex, creed, national origin, and other protected statuses. At PCI, Equity and Inclusion are core to our purpose: Together, delivering life-changing therapies. We are committed to an inclusive workplace, fostering understanding, fairness, respect, and equal opportunity at every level. We envision a community where everyone can belong and grow, and we strive to realize this through our practices, policies, and culture.
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