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Quality Specialist I Chemist Location: US-NC-Wilson Email this job to a friend
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Job Summary Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Assists in writing and performing method validations and method transfers. Assists in process validations. Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary. Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation. Primary Responsibilities Job Summary Performs a variety of chemical analysis and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Assists in writing and performing method validations and method transfers. Assists in process validations. Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary. Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation. Primary Responsibilities Education and Experience Requirements The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 0 2 years of laboratory experience. Necessary Knowledge, Skills, and Abilities Must demonstrate comprehension of at least one analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements. Must pass an internal GMP Training course and be computer literate Supervisory Responsibilities (if Applicable) There are no positions reporting to this position. Additional Information N/A Local candidates only and Science related BS degree with 0-2 years only. Hours: 7am 5:30 pm (some flexibility but shift is 10.5 hrs w/ hr unpaid meal period) Job Title: Quality Specialist - Chemist Duration: 12 months Location: Wilson, NC (Onsite) Notes: Free parking, Fitness Center, *4-day work weeks Facility Location | Wilson, NC, 27893 | Job Title-validate accuracy | Quality Specialist 1-Chemist | Department /Cost Center | 6100219, Quality Control-Wilson | Estimated Start Date | ASAP | Length of contract-13 weeks max | 12 months | Minimum Education Required | Bachelor's in chemistry or closely related science | Required Experience (i.e tele, med/surg, vents, etc) | Entry level position. Experience with GMP documentation, to show they have worked in a laboratory environment. Small molecule experience not required | Specialties Needed | N/A | Required Certifications (i.e. BLS, PALS, ACLS) | N/A | Shift Schedule (i.e 3x12, 5x8) | Monday-Thursday (10 hours); Possible OT hours | Shift Hours (i.e. 7A-7P) | Flexible, typically 7:00am-5:30pm | Weekends/Holidays Required? If Yes, how often? | Extended hours are typically on Fridays | Reason position open | | Bill rate range-validate Rate Card information | 37 | PO # | | Interview Process/Timeline | Panel Video interview- - 1st interview with hiring manager & management team.
- 2nd interview with peers/other chemist in the role.
| | | | Education and Experience Requirements The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 0 2 years of laboratory experience. Necessary Knowledge, Skills, and Abilities Must demonstrate comprehension of at least one analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements. Must pass an internal GMP Training course and be computer literate Supervisory Responsibilities (if Applicable) Alois Staffing -USA
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