Data Reviewer, Quality Control (2nd shift, Tues-Sat, 12;30pm to 9pm

MannKind Corporation; Danbury (CT); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player seeks a dedicated Quality Control Analyst to support quality systems and ensure product compliance. This role involves conducting HPLC and GC analyses, interpreting data, and maintaining laboratory equipment. The ideal candidate will bring extensive laboratory experience, particularly in the pharmaceutical sector, and a solid understanding of GMPs. Join a collaborative environment where your contributions will help uphold the highest standards of quality and safety in product development. If you are passionate about quality assurance and thrive in a fast-paced setting, this opportunity is for you.

Qualifications

• 5+ years of laboratory experience in the pharmaceutical industry.
• Understanding of GMPs and regulatory guidelines related to pharmaceuticals.

Responsibilities

• Conduct routine and non-routine HPLC/GC analyses according to SOPs.
• Compile data for documentation, including microbiological and chemical assays.
• Calibrate and maintain laboratory equipment.

Skills

HPLC

GC

Quality Control Systems

Data Analysis

Good Interpersonal Skills

Education

BS Degree in a Scientific Discipline

Tools

Access

Excel

Word

PowerPoint

Job description

At MannKind, our employees are our number one asset, and we are committed to building a tight-knit community where each of us plays a critical role in our collective success. We value diversity and depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Job Summary:

This role provides general support to maintain quality control systems within the company. The incumbent ensures that performance and products conform to established company and regulatory standards. They analyze finished formulations, raw materials, in-process materials, or stability samples using HPLC/GC, supporting the company’s quality program. The role involves interpreting and evaluating analyses for accuracy and precision, recommending corrective actions when necessary, and performing qualitative and quantitative tests using standard and advanced analytical equipment.

Working Hours: 12:30 pm to 9:00 pm, Tuesday to Saturday. Additional stipends are earned for working evening shifts and Saturdays.

Key Responsibilities:

1. Conduct routine and non-routine HPLC/GC analyses of raw materials, in-process, and finished formulations according to SOPs.
2. Perform chemical analyses to ensure product stability.
3. Compile data for documentation, including microbiological and chemical assays, stability testing, and formulation studies.
4. Calibrate and maintain laboratory equipment.
5. Participate in preparing investigations, summaries, and reports.
6. Assist in developing testing methods.
7. Review data for compliance and report abnormalities.
8. Update SOPs as needed.
9. Perform special projects related to analytical and instrument troubleshooting.
10. Apply GMP, GLP, and good record-keeping practices daily.
11. Follow written test methods and protocols.
12. Process, report, and visualize data; identify issues such as out-of-trend data. Communicate primarily within the QC organization.
13. Observe all company, health, safety, and environmental guidelines.

Additional duties may be assigned as necessary.

Qualifications:

• BS Degree in a scientific discipline with 5+ years of related experience or equivalent training and experience.
• At least 5 years of laboratory experience, preferably in the pharmaceutical industry.
• Experience with quality control systems.
• Understanding of GMPs and regulatory guidelines related to pharmaceuticals (preferred).
• Good interpersonal skills.
• Proficiency in Access, Excel, Word, and PowerPoint.