Supervisor, QC Microbiology, 2nd Shift
Company: Emergent BioSolutions
Location: Baltimore
Posted on: May 28, 2023
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Job Description:
We go where others won't, taking on some of the biggest public
health challenges to protect and enhance millions of lives, and
create a better, more secure world. Here, you will join passionate
professionals who advance their scientific, technical and
professional skills to develop products designed-to protect and
enhance life.
I. JOB SUMMARY
The Supervisor, QC Microbiology position supports the Quality
Control group at Emergent BioSolutions Camden Campus to maintain
process optimization and manufacturing activities. The Microbiology
Supervisor is responsible for maintaining a safe and professional
work environment. They will supervise the following activities in
support of the Microbiology, Environmental Monitoring, and Utility
testing programs, which includes microbiological product testing,
monitoring of the manufacturing production space, and supporting
quality initiatives. The individual may also conduct monitoring,
testing, SOP generation and revision, investigation, and
implementation of new microbiological programs as needed.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions.
--- Supervise operational activities of laboratory personnel in an
organized and efficient manner to prevent any delays in product
release.
--- Assist Microbiology Manager with all day-to-day production
issues as they arise.
--- Perform trend analysis for batch record turn around, deviations
and OOS investigations.
--- Implement quality improvement initiatives and corrective
actions.
--- Conduct microbiological qualitative and quantitative analyses
of samples.
--- Investigate, suggest, validate and implement new laboratory
procedures/techniques.
--- Provides expertise and troubleshoots microbiology related
issues.
--- Review record keeping and documentation of laboratory equipment
maintenance.
--- Review and update existing techniques, specifications, testing
standards and SOPs or write new documents.
--- Supervise and provide significant contribution to the
development and implementation of CGMP.
--- Document all procedures and results.
--- Represent department in meetings with Production, QA/RA,
Engineering and other related departments in the absence of the
Microbiology Manager.
--- Advise, recommend, and implement resolutions for quality issues
and non-compliance.
--- Maintain database of laboratory data tracking and trending.
--- Ensure that all equipment is fully calibrated and
validated.
--- Work with the Microbiology Manager to author Microbiology
related deviations, CAPA, OOS and OOL investigations.
--- Assist Method Validation in validation report generation and
review.
--- Identify and recommend equipment, supplies and vendors for
microbial analyses.
--- Guide the professional development of supporting staff both as
individual and as a group.
--- Participate in interviewing process for hiring supporting
staff.
--- Participate and attend professional seminars, conferences and
conventions.
The above statements are intended to describe the nature of work
performed by those in this job and are not an exhaustive list of
all duties. Nothing in this job description restricts managements
right to assign or reassign duties and responsibilities to this job
at any time which reflects management's assignment of essential
functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
To perform the job successfully, an individual should demonstrate
the following competencies to perform the essential functions of
this position.
--- Technical/Professional Knowledge-having achieved a satisfactory
level of technical and professional skill or knowledge in
position-related areas, keeping up with current developments and
trends in areas of expertise.
--- Delegation-the individual delegates work assignments, gives
authority to work independently, sets expectations and monitors
delegated activities.
--- Leadership-the individual inspires and motivates others to
perform well and accepts feedback from others.
--- Safety and Security-the individual observes safety and security
procedures and uses equipment and materials properly. May be
required to lift items that are approximately 25lbs.
--- Management Skills-the individual includes staff in planning,
decision-making, facilitating and process improvement; makes
self-available to staff; provides regular performance feedback; and
develops subordinates' skills and encourages growth.
--- Quality Management-the individual looks for ways to improve and
promote quality and demonstrates accuracy and thoroughness.
--- Planning/Organizing-the individual prioritizes and plans work
activities, uses time efficiently and develops realistic action
plans.
--- Stress Tolerance- maintaining stable performance under pressure
or opposition (such as time pressure or job ambiguity); handling
stress in a manner that is acceptable to others and to the
organization.
Desired Minimum Qualifications
Education and Experience:
--- B.S. in Microbiology/Biology or related field with a minimum of
5 years' experience in the Pharmaceutical or Biotechnology industry
and 2 years' experience in a supervisory/leadership role. OR an
M.S. with minimum of 3 years' experience including 1 year in
supervisory/leadership role.
--- Emphasis in aseptic processing, QC microbiology, environmental
monitoring, water systems, quality control, validation and
manufacturing processes is essential.
--- Must have previous hands-on experience with microbiological
methods such as Bacteriostasis and Fungistasis, Enhancement and
Inhibition, LAL, Sterility, Bioburden Testing.
Necessary Knowledge, Skills and Abilities:
--- Competent in the use of various computer programs of MS Access
and Excel.
--- Excellent communication, documentation and organizational
skills.
--- General knowledge of FDA regulations pertaining to cGMP's.
Note: The responsibilities and tasks outlined in this Job
Description are not exhaustive and may require other duties as
determined by the needs of the company.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT
CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees
working on site are vaccinated to help ensure their safety, as well
as the safety of fellow employees. This includes the use of good
judgment when determining when the CDC guidelines advise that you
stay home when ill.
There are physical/mental demands and work environment
characteristics that must be met by an individual to successfully
perform the essential functions of the job. This information is
available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with
disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and values the diversity of our workforce. Emergent does
not discriminate on the basis of race, color, creed, religion, sex
or gender (including pregnancy, childbirth, and related medical
conditions), gender identity or gender expression (including
transgender status), sexual orientation, age, national origin,
ancestry, citizenship status, marital status, physical or mental
disability, military service or veteran status, genetic information
or any other characteristics protected by applicable federal, state
or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions' approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions'
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
submitting agency.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy
to improve the quality of life for individuals around the world,
giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it
is our approach to product development, manufacturing, encouraging
employee health and wellness or giving back to the community-we
strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
Keywords: Emergent BioSolutions, Baltimore , Supervisor, QC Microbiology, 2nd Shift, Hospitality & Tourism , Baltimore, Maryland
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