QC Microbiologist

Job Description

ROLE SUMMARY:

The Quality Control Microbiology department is seeking a highly motivated candidate to support GMP microbial testing at the Sanford North site. The work includes testing of various microbial assays such as Environmental Monitoring (EM), Utility Monitoring (UM), Gas Testing, Sterility Testing, Bioburden testing, Endotoxin Testing, Growth Promotion, Micro ID, Data Review and other assays as needed for in-process, release, stability, etc. Focus areas to also include execution of analytical method qualification/validation protocols.

The candidate will be expected to support the Microbiology Laboratory such as authoring procedures, documents, stocking materials, inventory and other activities as necessary.

The successful candidate will be team oriented, have a "right the first time" attitude, detailed oriented, exhibit equity and inclusiveness and take initiative to learn and develop in the role to support the Microbiology Laboratory.

ROLE RESPONSIBILITIES:

Perform routine and non-routine environmental monitoring (total particulates, air viable and surface viables), utility monitoring and gas testing of GMP manufacturing clean rooms and lab areas

Initiate and participate in EM excursion investigations and assess any potential impact on product quality

Assist in trending and EM data and generate quarterly and yearly reports

Perform bioburden, endotoxin, sterility testing, Micro ID, TOC and Conductivity

Author standard operating procedures, assay qualifications and other GMP documents as necessary

Aid as necessary to maintain the function of the QC lab to include ordering materials, inventory, general housekeeping and other duties as necessary

Operate in high regard, integrity and efficiency to generate accurate and quality results with a customer focused mind-set

Utilize laboratory instruments and equipment in accordance to established procedures to include but not limited to air samplers, particle counters, endotoxin readers, microscopes, etc.

Perform instrument performance qualifications

Perform assay qualifications for in-process, drug substance, buffers, etc. and author reports

Perform analysis and data analysis of in-process, APIs, and stability samples using existing methods

Train and mentor other associates on lab assays

Author and review Quality Control SOPs

Maintain QC lab and provide assistance as needed during equipment and facility activities

Interact closely with other departments to ensure efficient, compliant and timely execution of product activities

Assist in investigation and review of GMP quality events to include deviations, out of specification reports and audit findings

Act as a QC Microbiology SME (Subject Matter Expert) during internal/external audits, risk assessments, and investigations

Operate under minimum supervisor and support special projects as needed

Support continuous improvement projects related to QC

Ability to author environmental monitoring excursion reports, deviations, CAPA and SOPs as needed

Demonstrated understanding of USP, EP and FDA microbiological testing requirements

Support Microbiological staff members as needed