<p>Work Flexibility: Onsite</p> <p>1st Shift: Mon - Fri 8:00 AM to 5:00 PM, OT as needed</p> <p>What you will do:</p> <p>The QC Analyst I will perform routine and complex analytical testing to support lot release, stability, and method development, while accurately documenting results and ensuring all work meets cGMP/cGLP standards.</p> <ul> <li>Perform routine procedures and complex analytical methods for lot release and stability testing of raw materials, reagents, and products, and prepare technical reports and documentation </li><li>Test and record measurements of various product attributes, including pH, concentration, identity, purity, impurities, and bio-potency. </li><li>Perform studies to qualify analytical standards, assay controls, and critical reagents. </li><li>Complete documentation to show that tests have been performed according to approved methods and that all results are recorded accurately. </li><li>Maintain laboratory operations in conformance with cGMP/cGLP standards. </li><li>Monitor and record equipment parameters (temperature charts, gas levels, and liquid nitrogen levels). </li><li>Monitor and maintain adequate quantities of laboratory supplies. </li><li>Assist the Quality Control team with technical evaluations of non-conforming test results and events to determine root cause; recommend corrective actions. </li><li>Participate in studies to develop and validate new analytical methods. </li></ul> <p>What you need:</p> <p>Required Qualifications</p> <ul> <li>Bachelor's degree in biology, biochemistry, microbiology or chemistry </li><li>Experience with various analytical equipment and methods· </li><li>Experience with the application of statistics for data analysis </li><li>Experience with computer software (WORD, Excel, etc.) </li></ul> <p>Preferred Qualifications</p> <ul> <li>Master's degree in biology, biochemistry, microbiology, or chemistry </li><li>1 - 2 years of recent and applicable industry experience, preferably in a pharmaceutical quality control laboratory </li><li>Advanced technical knowledge of analytical methods and function and maintenance of related instruments (including, but not limited to HPLC, UHPLC, UV/Vis spectrophotometers, SDS-PAGE, capillary electrophoresis, brightfield and fluorescence microscopy, cell counters, protein analysis) </li><li>Experience with aseptic technique and mammalian cell cultures </li><li>Experience with inspections, audits, and regulatory agencies/governing bodies. </li><li>Knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations </li><li>Experience maintaining qualified laboratory equipment and creating/reviewing technical documents for an FDA-regulated laboratory </li><li>Highly qualified candidates with alternate, but applicable experience will be considered, including related academic and commercial laboratory research.* </li></ul> <p>#INDGQO</p> <p>Travel Percentage: 10%</p> <p>Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.</p> <p>Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.</p>