Top 4 Qc analyst 1 Jobs in Middletown, De

QC Analyst, Microbial
WuXi AppTec —Middletown, DE
- Mid-level
- 1 year
- Associate's degree
7d
QC Analytical Scientist
WuXi AppTec —Middletown, DE
- Master's degree
- Bachelor's degree
- Continuous improvement
7d
QC Raw Material Scientist
WuXi AppTec —Middletown, DE
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
3d

Other jobs to consider

Find your next job by exploring related positions.

QC Analyst, Microbial
WuXi AppTec —Middletown, DE
The QC Analyst will support both startup and steady-state operations, working closely with the QC Microbiology Lead to ensure timely and accurate completion of…
7d
Quality Control PChem Analyst I or II
CLENE NANOMEDICINE INC —North East, MD
Ability to read, interpret, and follow technical documents, SOPs, and laboratory procedures. The Quality Control P-Chem Analyst I/II performs analytical testing…
$25 - $28 an hour
7d

I want to receive the latest job alert for qc analyst 1 in middletown, de

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

qc analyst 1 jobs near middletown, de

Scientist jobs in Middletown, DE

Medical Laboratory Scientist jobs in Tacoma, WA

Pharmaceutical Scientist jobs in New Jersey

Field Application Scientist jobs in Houston, TX

Clinical Laboratory Scientist jobs in Palo Alto, CA

Environmental Data Scientist Denver jobs in Colorado

Clinical Laboratory Scientist jobs in Baltimore, MD

Qc Technician jobs in Newton, NC

Cable Technician jobs in Philadelphia, PA

Ekg Technician jobs in Homestead, FL

Pharmacy Technician jobs in Meridian, ID

Qc Technician jobs in Maryland

Qc Technician jobs in Bohemia, NY

Qc Technician jobs in Valley Stream, NY

Clinical Laboratory Scientist jobs in Concord, CA

Food Scientist jobs in Minneapolis, MN

Scientist jobs in New Jersey

Clinical Laboratory Scientist jobs in New Jersey

Research Scientist jobs in Colorado

Environmental Scientist jobs in San Francisco, CA

QC Analyst, Microbial

WuXi AppTec -
Middletown, DE

Apply Now

Job Details

7 days ago

Qualifications

Data integrity assurance
USP standards
Pharmaceutical regulatory compliance
ICH guidelines
Pharmaceutical company experience
Pharmaceutical manufacturing facility experience

Full Job Description

Overview:

Reporting to the QC Microbiology Lead, the QC Analyst will perform routine and non-routine microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes microbiological testing, environmental monitoring, stability sample handling, equipment operation, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Analyst will support both startup and steady-state operations, working closely with the QC Microbiology Lead to ensure timely and accurate completion of QC tasks for product release, stability studies, and validation activities.

Responsibilities:

Microbiological Testing and Support

Perform microbial QC testing for drug products, raw materials, packaging components, and utilities in accordance with approved methods and SOPs.
Conduct tests such as environmental monitoring, bioburden, endotoxin, microbial limits, and microbial identification.
Accurately record and report test results in compliance with data integrity principles (ALCOA+).
Operate, calibrate, and maintain microbiology laboratory equipment according to GMP requirements.
Other QC tasks assigned by microbiology lead.

Regulatory Compliance and Documentation

Follow all cGMP, safety, and quality policies while executing microbiology laboratory activities.
Maintain complete, accurate, and inspection-ready microbiology laboratory records.
Assist in the preparation for client and regulatory audits, providing documentation and responding to inquiries.
Promptly notify the QC Microbiology Lead of any deviations, out-of-specification (OOS) results, or atypical findings.

Qualifications:

Associate or bachelor’s degree in Microbiology, Biology, or related scientific discipline.
1–3 years of QC microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment; internship or co-op experience considered.
Working knowledge of microbiological techniques and instrumentation.
Familiarity with GMP regulations, USP <61>, <62>, <85>, <1116>, ICH guidelines, and data integrity principles.

Preferred Qualifications

Experience with LIMS, Empower, or other electronic laboratory systems.
Previous work in a CDMO or multi-client environment.
Ability to work flexibly across analytical and microbiological testing areas as cross-trained.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Apply Now

Refine Your Search

qc analyst 1 jobs in middletown, de

QC Analyst, Microbial

QC Analytical Scientist

QC Raw Material Scientist

Other jobs to consider

I want to receive the latest job alert for qc analyst 1 in middletown, de

Explore jobs in more locations

Microbiological Testing and Support

Regulatory Compliance and Documentation

Job Seeker Tools

Employer Tools

Browse

Stay Connected