Chemist 1

Job Title: Chemist 1
Brief Job Description
The Chemist 1 is responsible for routine qualitative and/or quantitative analytical chemistry testing and data review 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 (Role may include shift work).
Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and/or tasks, etc. associated with this job title:

• 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 work.
• Performs testing on a range of samples, including chemical raw materials, components (including packaging materials), finished products, stability samples, water, and environmental samples.
• May perform sampling activities of various types in the facility (e.g., swabs.).
• Dispose of flammable materials in the <90 day accumulation container.
• Maintains and troubleshoots testing equipment.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Performs project work.
• Trains QC employees in GMP, SHE, QC methods and processes.
• Troubleshoots methods and processes.
• May serve as an expert in a specific area of laboratory equipment, process, or system.
• The incumbent is not necessarily performing all the Major Responsibilities of the role immediately.
• The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

Typical Accountabilities (per client framework and regulatory expectations):

• 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 on the client Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Ensures compliance with client Corporate 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
Essential

• Bachelor degree or a minimum of 3 years of demonstrated relevant experience in Quality Control lab setting.

Desirable

• Bachelor of Science degree, preferably in Chemistry or a related discipline.
• 2 years laboratory experience.
• High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.

Contact

Bhuvana Krishna

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