QC Microbiologist (Bioburden/Endotoxin)

Russell Tobin; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Russell Tobin is partnering with a leading Biopharma organization to identify a QC Microbiologist for an onsite opportunity in Holly Springs, NC. The role focuses on testing raw materials and environmental monitoring samples and requires adherence to GMP and data integrity standards.

Qualifications include a Bachelor’s degree in Biology or Microbiology and 2+ years of lab experience, with LIMS exposure preferred. This is a 12-month contract with potential extension.

Qualifications

• Bachelor’s degree in Biology or Microbiology required.
• 2+ years of laboratory experience preferred.
• Experience with environmental monitoring in manufacturing.
• GMP knowledge and data integrity familiarity a plus.

Responsibilities

• Perform testing of raw materials, environmental samples, utilities, and manufactured materials.
• Collect, test, review, and document QC microbiology samples per SOPs.
• Develop and maintain SOPs; build assay and lab technique expertise.
• Author investigations and assess invalid assays as needed.
• Support method validation and method transfer activities.
• Maintain GMP compliance, safety, and regulatory requirements.

Skills

Environmental monitoring

GMP compliance

Data integrity

Laboratory safety

Analytical mindset

Education

Bachelor's degree in Biology or Microbiology

Tools

LIMS

Laboratory instrumentation

Job description

Russell Tobin is partnering with a leading Biopharma organization to identify a QC Microbiologist for an opportunity in Holly Springs, NC.

Responsibilities

• Perform critical testing of raw materials, environmental monitoring samples, utilities, validation samples, and manufactured materials.
• Collect, test, review, and document QC Microbiology samples in accordance with quality and regulatory requirements.
• Perform testing and associated activities accurately and in accordance with applicable SOPs and protocols.
• Develop and maintain Standard Operating Procedures (SOPs) and build expertise in assigned assays and laboratory techniques.
• Author laboratory investigations and invalid assay assessments as required.
• Support method validation and method transfer activities.
• Maintain compliance with GMP, safety, data integrity, and applicable regulatory requirements.
• Perform shift work as needed to support laboratory and manufacturing operations.

Requirements

• Bachelor’s degree in Biology, Microbiology, or another related scientific discipline required.
• 2+ years of laboratory experience preferred.
• Experience performing environmental monitoring in manufacturing areas required.
• Experience working in an analytical testing laboratory, either academic or industry.
• Intermediate knowledge of GMPs, safety regulations, data integrity, analytical methods, and laboratory instrumentation.
• Experience in a cGMP pharmaceutical laboratory preferred.
• LIMS experience preferred.
• Experience with Bioburden, Endotoxin, and Sterility testing is a plus.

• Location model: 100% Onsite – Holly Springs, NC
• Schedule: Standard Business Hours, M-F, 8:00am-5:00pm
• Position Type: 12-month contract with possibilities of extension

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.