QC Analyst
5+ years
United States
Full-time
Remote
1 month ago
About the role
About The Company
WuXi AppTec is a leading global pharmaceutical, biotechnology, and medical device R&D service company dedicated to enabling the development of innovative medicines and healthcare products. With a commitment to scientific excellence and operational efficiency, WuXi AppTec offers comprehensive solutions across the entire drug development lifecycle, from discovery through manufacturing. The company operates state-of-the-art laboratories and manufacturing facilities worldwide, fostering a collaborative environment that promotes innovation, safety, and quality. WuXi AppTec’s mission is to accelerate the development of healthcare products that improve patients’ lives, making it an employer of choice for professionals seeking to contribute to impactful scientific advancements.
About The Role
Reporting directly to the QC Microbiology Lead, the QC Analyst plays a vital role in supporting microbiological testing and environmental monitoring activities essential for drug product manufacturing at WuXi AppTec’s Middletown, DE site. This position involves performing routine and non-routine microbiological assays, ensuring compliance with Good Manufacturing Practices (GMP), and maintaining thorough documentation to support product release, stability studies, and validation processes. The QC Analyst will work closely with cross-functional teams to ensure timely and accurate completion of laboratory tasks, uphold regulatory standards, and contribute to the overall quality assurance of pharmaceutical products. This role offers an excellent opportunity for professionals passionate about microbiology and quality control to contribute to innovative healthcare solutions in a dynamic, regulated environment.
Qualifications
Responsibilities
Benefits
WuXi AppTec offers a comprehensive benefits package designed to support the health, well-being, and professional growth of its employees. Benefits include competitive salary packages, health insurance plans, dental and vision coverage, retirement savings plans, paid time off, and holidays. Employees have access to ongoing training and development programs to enhance their skills and career progression. The company also promotes a collaborative and inclusive work environment, fostering innovation and teamwork. Additional perks may include wellness programs, employee assistance programs, and opportunities for internal mobility within the organization.
Equal Opportunity
WuXi AppTec is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are valued and respected. We do not discriminate against any individual based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by applicable laws. All qualified applicants will receive consideration for employment without regard to these factors. We believe that diversity drives innovation and excellence, and we are dedicated to fostering a work environment that reflects these values.
WuXi AppTec is a leading global pharmaceutical, biotechnology, and medical device R&D service company dedicated to enabling the development of innovative medicines and healthcare products. With a commitment to scientific excellence and operational efficiency, WuXi AppTec offers comprehensive solutions across the entire drug development lifecycle, from discovery through manufacturing. The company operates state-of-the-art laboratories and manufacturing facilities worldwide, fostering a collaborative environment that promotes innovation, safety, and quality. WuXi AppTec’s mission is to accelerate the development of healthcare products that improve patients’ lives, making it an employer of choice for professionals seeking to contribute to impactful scientific advancements.
About The Role
Reporting directly to the QC Microbiology Lead, the QC Analyst plays a vital role in supporting microbiological testing and environmental monitoring activities essential for drug product manufacturing at WuXi AppTec’s Middletown, DE site. This position involves performing routine and non-routine microbiological assays, ensuring compliance with Good Manufacturing Practices (GMP), and maintaining thorough documentation to support product release, stability studies, and validation processes. The QC Analyst will work closely with cross-functional teams to ensure timely and accurate completion of laboratory tasks, uphold regulatory standards, and contribute to the overall quality assurance of pharmaceutical products. This role offers an excellent opportunity for professionals passionate about microbiology and quality control to contribute to innovative healthcare solutions in a dynamic, regulated environment.
Qualifications
- Associate or bachelor's degree in Microbiology, Biology, or a related scientific discipline.
- 1-3 years of quality control microbiology experience within a GMP-regulated pharmaceutical or biotechnology setting; internship or co-op experience will be considered.
- Proficiency in microbiological techniques and familiarity with laboratory instrumentation.
- Knowledge of GMP regulations, USP, ICH guidelines, and data integrity principles.
- Strong attention to detail, organizational skills, and the ability to work independently and as part of a team.
Responsibilities
- Perform microbiological testing on drug products, raw materials, packaging components, and utilities following approved methods and SOPs.
- Conduct environmental monitoring, bioburden, endotoxin, microbial limits, and microbial identification tests.
- Accurately document and report test results, ensuring compliance with data integrity principles (ALCOA+).
- Operate, calibrate, and maintain microbiology laboratory equipment in accordance with GMP standards.
- Support environmental monitoring programs and stability testing activities to ensure ongoing compliance and product quality.
- Assist in investigations of deviations, out-of-specification (OOS) results, and atypical findings, escalating issues as necessary.
- Prepare and review laboratory documentation, including testing records, validation protocols, and reports.
- Participate in internal and external audits by providing documentation and responding to inquiries.
- Maintain a safe and compliant laboratory environment by adhering to safety policies and procedures.
- Collaborate with cross-functional teams to support continuous improvement initiatives and operational excellence.
Benefits
WuXi AppTec offers a comprehensive benefits package designed to support the health, well-being, and professional growth of its employees. Benefits include competitive salary packages, health insurance plans, dental and vision coverage, retirement savings plans, paid time off, and holidays. Employees have access to ongoing training and development programs to enhance their skills and career progression. The company also promotes a collaborative and inclusive work environment, fostering innovation and teamwork. Additional perks may include wellness programs, employee assistance programs, and opportunities for internal mobility within the organization.
Equal Opportunity
WuXi AppTec is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are valued and respected. We do not discriminate against any individual based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by applicable laws. All qualified applicants will receive consideration for employment without regard to these factors. We believe that diversity drives innovation and excellence, and we are dedicated to fostering a work environment that reflects these values.
Skills
Book and Periodical PublishingQuality Assurance