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

MannKind; Danbury (CT); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control Analyst to ensure that products meet regulatory standards and quality benchmarks. This role involves conducting HPLC and GC analyses, maintaining laboratory equipment, and compiling essential data for documentation. If you have a strong background in quality control systems and a passion for ensuring product integrity, this position offers an exciting opportunity to contribute to innovative pharmaceutical solutions. Join a dynamic team where your expertise will help shape the future of quality assurance in the industry.

Qualifications

• 5+ years of experience in a laboratory setting, preferably in pharma.
• Understanding of GMPs and regulatory guidelines as they relate to pharmaceutical products.

Responsibilities

• Conduct routine and non-routine HPLC/GC analysis of raw materials and formulations.
• Compile data for documentation of test procedures including microbiological and chemical assays.
• Calibrate and maintain lab equipment, ensuring compliance with specifications.

Skills

HPLC Analysis

GC Analysis

Quality Control Systems

Good Manufacturing Practices (GMP)

Data Analysis

Documentation Skills

Interpersonal Skills

Written Communication

Education

BS Degree in a Scientific Discipline

Tools

Microsoft Access

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Job Summary:

Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes finished formulations, raw materials, in-process materials, or stability samples by HPLC/GC, in support of the company’s quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.

Working Hours: 12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays.

Essential duties and key job responsibilities:

1. Conduct routine and non-routine HPLC/GC analysis of raw materials, in-process, and finished formulations according to standard operating procedures.
2. Perform chemical analyses of product to ensure stability.
3. Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
4. Calibrate and maintain lab equipment.
5. Participate in the preparation of investigations, summaries, and reports.
6. May assist in developing testing methods.
7. Review data obtained for compliance to specifications and report abnormalities.
8. Revise and update standard operating procedures as needed.
9. May perform special projects on analytical and instrument problem solving.
10. Apply knowledge of good manufacturing practices, good laboratory practices, and good record keeping practices on a daily basis.
11. Follow written test methods and protocols.
12. Process data, report data, and prepare tables and graphs for the completed testing. Identify problems, e.g., out of trend data. Professional interactions are primarily within the QC organization.
13. Responsible for observing all Company, Health, Safety, and Environmental guidelines.

Additional duties may be assigned as necessary.

Qualifications:

• BS Degree in a scientific discipline with 5+ years related experience or an equivalent combination of training and experience.
• At least 5+ years' experience in a laboratory setting, preferably in pharma.
• 5+ years’ experience in quality control systems.
• Good written communication skills.
• Understanding of GMPs and regulatory guidelines as they relate to pharmaceutical products (preferred).
• Good interpersonal skills.
• Proficiency in Access, Excel, Word, and PowerPoint.