Quality Specialist I - Chemist
Employment Type : Full-Time
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:- Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
- Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
- Operate and maintain all analytical instrumentation and equipment as per established procedures.
- Write, revise, develop and evaluate operational and maintenance procedures.
- Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
- Provide training and assistance to other group members.
- Actively participate in investigations, problem solving and troubleshooting.
- Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
- Re-stock chemicals and consumables used in analysis.
- Prepare and present data summaries (written and oral) as necessary.
- Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
- Performs other related assignments and duties as required and assigned.
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.
Summary of Work:- Entry level Chemist (Quality Specialist I) 1-2 years experience, HPLC, Dissolution testing, LIMS and Empower software experience is a perk.
- Local candidates only and recent graduates are of most interest (BS/MS in Chemistry is mandate)
- Hours: 7am 5:30 pm (some flexibility but shift is 10.5 hrs w/ 1D2 hr unpaid meal period)