Supervisor, Qc Microbiology 2Nd Shift

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JOB SUMMARY
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.
JOB DUTIES

• 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 writes 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.

PROFESSIONAL SKILLS

• 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

EXPERIENCE

• Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology
• Previous experience in aseptic manufacturing highly preferred

EDUCATION

• 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

QUALITIES

• 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

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• 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.
• May occasionally support off shift activities.

COMMUNICATIONS & CONTACTS

• Works closely with Quality Assurance, Operations, and Facilities staff in performing varied work procedures and activities

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• Manages and develops subordinate staff
• Assigns responsibilities and duties within the group
• Provides constructive feedback to team and authors performance reviews within corporate timelines

TRAVEL

• <10%. Travel generally consists of routine daily movement between buildings.

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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.