Chemistry/Quality Assurance

Job Responsibilities:

Perform qualitative and/or quantitative analytical chemistry testing on pharmaceutical raw materials, components, and/or finished products according to policy and procedures at consistently high levels with a focus on quality and efficiency Performs data review activities as required. ▪ Participates in and may lead some QC Team Discussions. ▪ Maintains adequate inventories of reagents, glassware and other supplies. ▪ Maintains current, complete, legible notebooks and laboratory records in compliance with good scientific and regulatory practices. ▪ Writes and executes laboratory investigations for known lab errors and Out of Specification (OOS) results using the current electronic deviation system and/or other QC procedures. ▪ Participates in investigations for PET process areas related to QC processes or data. ▪ Trains QC employees in good analytical techniques, methods and instrumentation based on expertise. ▪ Troubleshoots methods and processes. ▪ Executes laboratory processes in compliance with GMPs, site and corporate policies, standard operating procedures (SOPs) and test methods. Immediately reports deviations that have the potential to compromise product quality. ▪ The role may include shift and weekend work. ▪ Performs testing on a range of samples, including finished products, water, and environmental samples. ▪ May perform sampling activities of various types in the facility (e.g., swabs.). ▪ Dispose of flammable materials in the accumulation container. ▪ Maintains and troubleshoots testing equipment. ▪ Provides and follows up on ideas for continuous improvements in laboratory processes. ▪ Troubleshoots methods and processes. ▪ May serve as an expert in a specific area of laboratory equipment, process, or system.

Typical Accountabilities:

Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training. ▪ Ensures compliance with policies and directives, site Standard Operating Procedures, site policies, work instructions, regulatory requirements, and industry best practice (cGMPs, GAMP, ITIL, PMI). ▪ Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures. ▪ Immediately report potential unsafe conditions to management. ▪ Supports internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections ▪ Participates in the investigation and resolution of product quality problems

Education, Qualifications, Skills and Experience- Essentials:

minimum of 3 years of experience

Schedule:

4x10 schedule 2nd shift 12p-10:30p Mon-Thurs or Tues-Fri 3rd shift 10p-8:30am Mon-Thurs •Must train on 1st shift 6-8 weeks (6am-2pm) demonstrated relevant experience in Quality Control lab setting.

Desirable:

Bachelor of Science degree OR lab experience ▪ working knowledge or experience of GMP environment

Job Type:

Full-time Pay:

$28.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person