Supervisor, QC Microbiology

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. assigned.
** Work Environment:
** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
*
* Qualifications:

*
* * Master's Degree in Microbiology, biology or similar life science preferred with at least 3-5 years’ experience in Pharma or Biotechnology Quality Control cGMP
* Alternatively, a BS Degree in Microbiology, biology or similar life science with greater than 5 years of intensive experience may be considered
* Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology
* Previous experience in aseptic manufacturing highly preferred#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients.
** Equal Employment Opportunity (EEO) Statement:*
* * PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
** At PCI, Equity and Inclusion are at the core of our company’s purpose:
Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*###

Responsible for the day-to-day operations of the QC Microbiology laboratory which include overseeing the environmental monitoring of classified spaces and the routine testing of the USP controlled utility systems and applicable microbiological assays of in-process samples and finished product. Ensure the timely testing and release of all samples. Relies on previous experience, analytical skill, 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 essential duties and responsibilities include the following but other duties may be
* Supervise lab personnel and provide oversight for personnel work schedules.
* Mentor and develop staff to meet technical and business needs.
* Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring and water/clean steam data for NH PCI facility sites and write quarterly reports summarizing these data.
* Perform and document investigations into Environmental Monitoring excursions and incidents
* which occur during aseptic filling and routine monitoring.
* Perform risk assessments and investigations with effective CAPAs.
* Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes.
* Performs initial identification of microbial contaminants and/or isolates.
* Oversee and perform as necessary endotoxin, bioburden, growth promotion of media, environmental monitoring, and critical utilities collection and testing.
* Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation.
* Maintain positive relationship and network effectively across sites, organizations, and clients.
* Ensure cGMP compliance of all activities performed and on time delivery of quality results.
* Write and…