Overview
Quality Control, Data Reviewer/Shift: Tues-Sat Jobs in Danbury, Connecticut, USA at MannKind
Position: Quality Control, Data Reviewer (Shift: Tues-Sat, 12:30pm to 9pm)
At Mann Kind 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 Mann Kind 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 Mann Kind 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
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Title: Quality Control, Data Reviewer/Shift: Tues-Sat
Company: MannKind
Location: Danbury, Connecticut, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager)
