QC Analyst, Microbial Job at WuXi AppTec, Middletown, DE

cjVPU2NjQy92VU9xcjk5YzVlWmZpbVdRcFE9PQ==
  • WuXi AppTec
  • Middletown, DE

Job Description

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.

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.
  • 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.

 

 

Job Tags

Internship

Similar Jobs

SDV Construction, Inc.

Business Development Manager - Commercial Construction Job at SDV Construction, Inc.

 ...Commercial Construction -Business Development Manager SDV Construction is looking for ahigh-performing Business Development Manager to help expand our presence acrossNew Mexico and the Southwest. This role is built for someone who understands that successful... 

Hancock Claims Consultants Technicians

Field Roof Inspector (McKean, PA) Job at Hancock Claims Consultants Technicians

 ...established process ensures top-tier claims support, ranging from rapid catastrophe response to direct inspections. As a RoofField Inspector , you'll be part of our dynamic network of independent contractors, conducting assessments on steep and high roofs, evaluating... 

Signify Health

Nurse Practitioner for In-home Visits Job at Signify Health

 ...relationships to make people healthier. Were hiring board-certified nurse practitioner contractors to conduct In-home Health Evaluations for...  .... They are so much more comfortable without the stress of travel or getting to an appointment on time. We also have the time to... 

Omni Inclusive

Gen AI with Python -Senior Engineer Job at Omni Inclusive

 ...Experience in working with and fine-tuning Large Language Models (LLMs), GEn AI, including the design, optimization of NLP systems, frameworks, and tools. Experience in building scalable applications using LLMs, utilizing frameworks such as LangChain, LlamaIndex, etc... 

two marshmallows llc

OTR Class A CDL Driver Job at two marshmallows llc

 ...Job Description Job Description We are looking for a self-motivated and customer service-oriented individuals. As a CDL Truck Driver you will be responsible for the safe operation of a commercial vehicle and the reliable delivery of our clients' products. We...