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

BioCT Innovation Commons; Connecticut; On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control Analyst to join their team. This role involves ensuring product quality through rigorous HPLC/GC analysis and compliance with regulatory standards. The ideal candidate will have a strong background in laboratory practices, particularly within the pharmaceutical sector, and will contribute to maintaining high quality control systems. With a commitment to excellence and teamwork, you will play a vital role in the organization’s mission to deliver top-notch products. If you are detail-oriented and passionate about quality assurance in pharmaceuticals, this opportunity is perfect for you.

Qualifications

• 5+ years in a laboratory setting, preferably in pharma.
• Strong understanding of GMPs and regulatory guidelines.
• BS Degree in a scientific discipline required.

Responsibilities

• Conduct routine and non-routine HPLC/GC analysis.
• Compile data for documentation of test procedures.
• Calibrate and maintain lab equipment.

Skills

HPLC/GC analysis

Quality control systems

Good Manufacturing Practices (GMP)

Good Laboratory Practices (GLP)

Data analysis and reporting

Interpersonal skills

Written communication

Education

BS Degree in a scientific discipline

Tools

Microsoft Access

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

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

• Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures.
• Perform chemical analyses of product to ensure stability.
• Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
• Calibrate and maintain lab equipment.
• Participate in the preparation of investigations, summaries and reports.
• May assist in developing testing methods.
• Review data obtained for compliance to specifications and report abnormalities.
• Revise and update standard operating procedures as needed.
• May perform special projects on analytical and instrument problem solving.
• Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
• Follows written test methods and protocols.
• 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.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

• 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 the pharmaceutical products preferred
• Good interpersonal skills
• Access, Excel, Word and Power Point skills