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.
Job Tags
Local area,