Job Description

Position Summary:

Analytical Technician will ensure the quality and reliability of products thought physical/chemical testing and evaluation against a defined specification range. Assist and aid in company understanding of cGMP quality systems. Use of proper laboratory practices to evaluate samples of: raw material, stability, in-process samples, finished bulk, and finished product.

Responsibilities

• Prepare samples for testing raw materials, longitudinal stability, in-process, and finished products.
• Physical and chemical testing in accordance with standard procedures, utilizing wet-chemistry and instrumental techniques.
• Operation and maintenance of scientific instruments including but not limited to HPLC, GC-FID, GCMS, TOC, EDX, UV-vis, and FTIR.
• Write, review, and execute validations of assay methods.
• Maintain accurate, up-to-date and concise laboratory notebooks and records.
• Work closely as a team to complete all required tasks in a timely manner.
• Monitor product quality to ensure compliance to standards and specifications.
• Understand and precisely follow Standard Operating Procedures, global methods, local methods and published standard or compendia methods i.e. USP, ISO, ASTM.
• Understand and apply basic laboratory safety instructions, reagent handling precautions, and disposal of chemical waste according to local environmental regulations.
• Communicate with other departments regarding production, stability, and other business goals.
• Participate in/lead OOS investigations and other issues encountered in the analytical lab.
• Maintain inventory of required equipment and consumables.
• Manage time and assigned projects effectively

Required Skills/Abilities

• Knowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handling
• Technical writing, verbal and interpersonal communication skills
• Robust analytical knowledge, critical thinking and problem-solving skills
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively with members of organization and levels of management
• Ability to work independently in a fast-paced environment
• Willingness to grow and adapt to change and structure.
• Proficient knowledge of computers and Microsoft Office.

RequiredEducation and Experience

• BS degree in Chemistry, Biology or related field

Preferred Education and Experience

• 0-2 years of experience in a manufacturing and/or Quality Control area
• Working knowledge of FDA 21 CFR part 210 and 211 requirements.

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