KNOWLEDGE SKILLS AND ABILITIES
- Previous experience is required in QC lab or QC stability program in a pharmaceutical or biotech environment
- Understanding roles of QA and QC in an organization
- Ability to think critically and creatively to identify and solve scientific problems
- Ability to multitask and organize time efficiently
- Strong interpersonal skills and excellent oral and written communication skill a must
- Works effectively with others as part of a team
- Physical ability to lift up to 40lbs and work at the lab bench for extended periods of time
EDUCATION AND/OR EXPERIENCE
- Minimum BS Chemistry or related science
- 5+ years of experience preferred
- Experience in FDA regulated industry.
- Strong knowledge of and troubleshooting of HPLC, UPLC, and UV vis
- Effective organization and planning skills
- Efficient in troubleshooting laboratory equipment
- Knowledge of good documentation practices Knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
CERTIFICATIONS, LICENSES, AND REGISTRATIONS
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The requirements listed below are representative of the knowledge, skill and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Majority of time can be spent wearing protective laboratory attire (Examples of attire include: goggles, gloves, lab coat)
- Minimal exposure to physical risks, such as operating dangerous equipment or working with chemicals
- Some travel possible but not frequent
- Must be able to lift 40 pounds
- Must be able to stand for long periods of time
- Must be able to sit in front of computer for long periods of time
- Fine motor skills must be sufficient to manipulate pipettes
- Corrected vision close to 20/20 and acceptable for driving
JOB TITLE: Sr. QC Analytical Chemist
FLSA STATUS: Exempt
REPORTS TO: QC Chemistry Laboratory Manager
LOCATION: Houston, TX
The Sr QC Analytical Chemist will perform quantitative and qualitative analysis of compounded admixed product for distribution to customers nationwide. The successful candidate must have extensive, hands-on experience in stability programs as well as the development and validation of stability-indicating and quantitative assays in cGMP environment. Proven ability to develop highly specific analytical methods for a wide variety of small/generic compounds. Exceptional cGMP documentation skills are a must for this position. Ability to adapt to a fast pace, high through-put, dynamic environment where priorities can change rapidly.
Mentors less experienced analysts.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensures a robust and ICH/GMP compliant Stability Program is established and maintained for all products.
- Development and qualification of stability indicating analytical methods for lot release and stability testing of products
- Provide support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.
- Generate and execute equipment and method validations and qualifications
- Prepare scientific reports and documents, present analytical findings and use scientific literature to solve advanced technical problems.
- Prepare and review SOPs, test methods, scientific reports and other GMP/regulatory documentation
- Review data generated by other analysts
- Independently apply scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems
- Mentors and trains junior chemist and scientist and acts as an analytical chemistry resource for other staff
- Participate in project management activities including: creating and meeting objectives for timelines, budgets, and project goals
- Troubleshoots analyses and equipment and performs investigations
- Performs routine testing when required