Quality Control Analyst I

Experience in microbiological testing including bioburden testing, microbial limit testing, bacteria endotoxin, microbial identification via gram stain, sterility testing, and preservative efficacy testing. Doesn’t need to have all the microbiological testing experience indicated above but should have some. Additionally, knowledge of USP, ISO guidelines, LIMS system is recommended. Good technical, communication and people’s skills are key competency.

EEO:- Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans

Conduct routine and non-routine biological and microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
Compile biological test data and perform appropriate statistical or trend analyses.
Calibrate, validate, or maintain biological lab equipment.
Complete documentation needed to support biological testing procedures, including data capture forms and equipment logbooks.
Evaluate biological testing methods and procedures for potential improvements.
Identify biological quality problems and recommend solutions.
Interpret biological test results, compare them to specifications, and make recommendations on data suitability for release.
Investigate or report questionable biological test results.
Monitor biological testing procedures to ensure compliance with established specifications and protocols.
Participate in out-of-specification and contamination investigations and recommend corrective actions.
Perform validations or transfers of biological and microbiological methods in accordance with applicable guidelines.
Prepare or review method transfer documentation for biological assays, including technical transfer protocols or reports.
Review data from contract microbiology labs to ensure accuracy and regulatory compliance.
Receive and inspect biological raw materials (e.g., cell lines, reagents, growth media).
Supply biological quality control data necessary for regulatory submissions.
Write or revise standard operating procedures for biological and microbiological quality control.
Write technical reports or documentation such as deviation reports, biological testing protocols, and microbial trend analyses.
Coordinate biological and microbiological testing with contract laboratories and vendors.
Serve as a technical liaison between microbiology/biology labs and other departments, vendors, or contractors.
Evaluate new biological technologies and methods (e.g., PCR, ELISA, flow cytometry) and recommend their implementation.
Identify and troubleshoot issues with biological testing equipment (e.g., incubators, autoclaves, biosafety cabinets).
Participate in internal assessments and audits related to biological testing and biosafety compliance.
Perform visual inspections of biological samples and finished products for contamination or abnormalities.
Train other analysts to perform biological assays and microbiological procedures.
Develop and qualify new microbiological or biological testing methods (e.g., microbial limits, endotoxin testing, cell-based assays).
Ensure that lab cleanliness and biosafety standards are maintained, including proper handling and disposal of biological materials.