Supervisor, QC Microbiology

PCI Services•Bedford, NH

34d

About The Position

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 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.

Requirements

Self-motivated with a drive for excellence; able to inspire and motivate staff
Positive attitude and strong interpersonal skills
Honesty, integrity, respect and courtesy with all colleagues
Able to work in a highly complex environment with competing demands and priorities
Able to deal with ambiguity
Excellent organizational skills
Strong oral and written communication skills
Proficient in statistical and data analysis
Ability to multi-task
In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs
Must be able to work at all NH PCI sites inclusive of remote locations
Ability to gown and work in an ISO environment
Able to lift to 20 lbs.
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

Nice To Haves

Previous experience in aseptic manufacturing highly preferred

Responsibilities

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 review standard operating procedures and coordinate method development and validation of microbiological methods.
Work and guide personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with regulatory guidance.
Manages and develops subordinate staff
Assigns responsibilities and duties within the group
Provides constructive feedback to team and authors performance reviews within corporate timelines