Job Description
Job DescriptionDescription:
Summary: Quality Control Scientist is responsible for leading multiple projects in a GMP/GLP environment involving analytical test methods in a cross-functional setting. QC Scientist will serve as Subject Matter Expert (SME) in method development, optimization, validation, and troubleshooting instruments (HPLC, GC, UV Spectroscopy, TOC, etc.) / test methods. QC Scientist will partner with contracted labs to oversee the development and validation of analytical methods. QC Scientist will work with the Validation team to coordinate testing related to validation tasks and support the QC Manager in various tasks to support business needs.
Essential Duties and Responsibilities
- Oversee test method validation execution
- Develop analytical test methods
- Author and maintain test method procedures and forms in the current state
- Author analytical test method validation protocols and reports
- Qualify test method for formulation grouping
- Troubleshoot technical issues with methods and instrument operation
- Serve as SME on analytical test methods and instrument operation
- Lead method technology transfer activities with contracted labs
- Process and interpret chromatographic data independently, and communicate the significance of the validation results to management
- Review analytical data for accuracy and release/reject results
- Perform analytical testing for validation support
- Develop/reverse engineer formulations to support new product strategy
- Develop raw material, in-process, bulk, and finished good specifications for new products
- Support the development of new product scale-up activities (order of ingredient addition, mixing speeds, mixing time, temperature, etc.)
- Troubleshoot formulation-related issues
- Coordinate with team members to ensure seamless analytical testing coverage for manufacturing operations and validation activities
- Train QC personnel on analytical testing and equipment operations
- Lead qualification activities with QC instruments
- Provide project progress updates and communicate cross-functional dependencies to achieve results.
- Keep current on new technologies and literature related to analytical test methods
- Maintain documentation, equipment, and work area in orderly condition at all times.
- May be required to perform other QC duties as assigned by management
Supervisory Responsibilities: This position has no supervisory responsibilities.
Department: Quality Control
Reports To: Director of Quality
Requirements:
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- Minimum of a bachelor’s degree in chemistry or related scientific field. A master’s degree is preferred.
- 7+ years of laboratory experience in a regulated industry (pharmaceutical, dietary supplement, biotech, etc.) with 5+ years of experience in method development and validation.
- Knowledge, Skills, and Abilities
- Excellent organizational skills in management of data, reagents, and equipment
- Expertise in performing analytical methods, maintaining, and troubleshooting (HPLC, FTIR, GC, UV Spectroscopy, etc.)
- Working knowledge/experience with chromatographic data acquisition systems
- Working knowledge/experience of data integrity and GMP/GLP requirements
- Working knowledge/experience of USP/AOAC.
- Experience working in a regulated (i.e., FDA, NPA, etc.) GMP environment is required.
- Experience in maintaining data integrity is required.
- Hands-on experience with chromatography equipment is required.
- Experience with EP, BP, ACS, and ICH guidelines is preferred.
- Experience reviewing audit trails
- Experience with Agilent GC, Waters HPLC equipment, Empower 3 Chromatography Software, and TOC is preferred.
- Experience with preventive maintenance and calibration of instruments is preferred.
- Ability to work under pressure and with a sense of urgency to deliver results on schedule with minimal supervision.
- Able and willing to work in a team environment and participate in cross-functional team activities.
- Ability to write routine reports and correspondence.
- Ability to train others.
- Discipline to consistently follow SOPs, GMPs, and safety precautions.
- Strong analytical reasoning skills & excellent written and verbal communication skills.
- Knowledgeable in Microsoft Office, Outlook, and similar programs.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms. The employee is frequently required to stand, walk, and talk or hear. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
This job description is subject to change at any time.