Quality Control, Microbiologist
Company: Discover International
Location: Santa Monica
Posted on: January 27, 2023
|
|
Job Description:
*Position Summary* The QC Microbiologist Contractor is
responsible for compendial and rapid microbiology laboratory
methods, serves as the technical lead for evaluation, validation,
and implementation of new microbiology methods and EM program. This
individual will work closely with functional technical operation
teams supporting the organizational vision. This role is based in
Santa Monica, CA and reports to Director of Quality. *Essential
Functions and Responsibilities* Author, review and execute SOPs,
Protocols, Reports relating to GMP microbiology processes, test
methods and related equipment maintenance Participate and support
regulator audits Implement, maintain, and oversee environmental
monitoring program, personnel monitoring, trending and analysis
Oversight of microbiology programs such as growth promotion,
bioburden, BacT/ALERT rapid sterility, compendial sterility, and
endotoxin methods. Conduct investigations regarding environmental
monitoring (EM) action level excursions, and out of specifications
(OOS) results for microbiological testing. Oversee and perform the
day-to-day activities related to Environmental Monitoring, product
release testing, and contamination control. Perform other related
duties and responsibilities as assigned. *Required
Skills/Abilities* Demonstrated knowledge of regulatory guidance and
industry best practices Strong knowledge and experience in several
of the following areas of competency: aseptic processing, clean
room and contamination control, environmental monitoring
microbiological methods and cleaning validation. Expert knowledge
and understanding of Microbiology principles, theories, concepts
and laboratory methodologies. Must demonstrate effective
organizational skills and ability to manage multiple projects. Must
have demonstrated experience analyzing and interpreting technical
results and summarizing these results in technical reports. Strong
knowledge of aseptic manufacturing and EM processes Comfortable in
a fast-paced small company environment with minimal direction and
able to adjust workload based upon changing priorities. *Education
and Experience* Master's Degree in a related science plus 4+ years
of GXP experience in the biotech and/or pharmaceutical industry
specific to microbial contamination and controls *OR* Bachelor's
Degree in a related science and 6+ years of GXP experience in the
biotech and/or pharmaceutical industry specific to microbial
contamination and controls *Physical Requirements* The physical
demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly
required to: Sit and talk or hear. The employee frequently is
required to use hands to finger, handle, or feel. The employee is
occasionally required to stand, walk, and reach with hands and
arms. The employee must occasionally lift and/or move up to 10
pounds. Specific vision abilities required by this job include
close vision and ability to adjust focus in order to read. The
noise level in the work environment is usually moderate. This
position requires working with biological and/or chemical hazards
Job Type: Contract Pay: $45.00 - $55.00 per hour Benefits: * 401(k)
* Dental insurance * Health insurance Schedule: * 8 hour shift
Ability to commute/relocate: * Santa Monica, CA: Reliably commute
or planning to relocate before starting work (Required) Experience:
* working in a biopharma: 2 years (Preferred) Work Location: One
location
Keywords: Discover International, Santa Monica , Quality Control, Microbiologist, Other , Santa Monica, California
Click
here to apply!
|