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Supervisor, Qc Microbiology Jobs

Company

PCI Pharma Services
Address , Madison, Wi
Employment type FULL_TIME
Salary
Expires 2023-06-09
Posted at 1 year ago
Job Description
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.

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
  • Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring and water/clean steam data for PCI facility sites and writes quarterly reports summarizing these data.
  • Supervise lab personnel and provide oversight for personnel work schedules.
  • Maintain positive relationship and network effectively across sites, organizations and clients.
  • Write and review standard operating procedures and coordinate method development and validation of microbiological methods.
  • Ensure cGMP compliance of all activities performed and on time delivery of quality results.
  • Oversee and perform as necessary endotoxin, bioburden, growth promotion of media, environmental monitoring, and critical utilities collection and testing.
  • Mentor and develop staff to meet technical and business needs.
  • Perform risk assessments and investigations with effective CAPAs.
  • Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation.
  • Work and guide personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with regulatory guidance.
  • 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.
  • Perform and document investigations into Environmental Monitoring excursions and incidents which occur during aseptic filling and routine monitoring.
PROFESSIONAL SKILLS
  • Excellent organizational skills
  • Strong oral and written communication skills
  • Ability to multi-task
  • Proficient in statistical and data analysis
  • In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs
EXPERIENCE
  • Previous experience in aseptic manufacturing highly preferred
  • Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology
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
  • Able to work in a highly complex environment with competing demands and priorities
  • Positive attitude and strong interpersonal skills
  • Honesty, integrity, respect and courtesy with all colleagues
  • Able to deal with ambiguity
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
  • Must be able to work at all 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.
  • #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 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.