QC Sr. Chemist

Job Description

Job DescriptionDescription:

Job Title: QC Sr. Chemist

Department: Quality Control

Reports To: Manager, QC

FLSA Status: Exempt

Summary: The QC Sr. Chemist will be involved in multiple on-going projects and will serve in a cross-functional role. Activities include performing analysis in a GMP/GLP environment for release testing, supporting manufacturing functions (engineering, validation, etc.), stability studies, method validation and transfer in a SDMS environment. This individual will lead raw material, intermediates, and finished products release in QC laboratory.

The individual should have good communication and organizational skills and be able to coordinate work with cross-functional team members, peers, and external Laboratories and CMOs (Contract Manufacturing Organizations). The Sr. Chemist will serve as a mentor/trainer to Chemist.

Essential Duties and Responsibilities:

• Perform testing using analytical equipment (HPLC-MS, HPTLC-MS, GC-MS, IR, UV, TOC, etc.) as well as using traditional wet chemistry methods (i.e. titration, TLC, etc.)
• Serve as in-house Subject Matter Expert on Instrument operation, including but not limited to HPLC, GC, HPTLC, FTIR, etc.
• Work under minimal to no supervision.
• Participate in Technical Transfer and method development activities with the Scientist, validation personnel and/or contract labs.
• Perform analytical method transfer, and validation as directed from provided protocols.
• Investigate deviations and write exception/ OOS/OOT documents. Own/follow up on CAPAs.
• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.
• Process and interpret chromatographic data independently and communicate significance of results to management, while maintaining Data Integrity standards.
• Enter experimental information into lab notebooks and process analytical data accordingly.
• Coordinate with team members to ensure seamless analytical coverage during manufacturing campaigns and on-going stability studies.
• Coordinate with team members to verify each other’s data by reviewing in a timely manner.
• Take personal responsibility to meet analytical testing and data verification deadlines.
• Review analytical data for accuracy and release/reject results.
• Maintain documentation, equipment and work area in orderly condition at all times.
• Initiate/facilitate improvement projects to drive efficiency of the laboratory performance.
• Serve as mentor/trainer to Chemist and Laboratory Coordinator.
• Facilitate/ initiate projects that may improve laboratory compliance and laboratory output.
• Participate in audits.
• Proactively and cooperatively connect with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
• May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities: This position has no supervisory responsibilities.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

• Must have a Bachelor’s degree in Chemistry or related science with 6 + years’ experience in a regulated industry (i.e. pharmaceutical, dietary supplement, biotech, etc.); or equivalent combination of education, training and/or experience.
• 4 + years of experience with USP/AOAC is required.
• Experience with analytical method verification, development, validation or transfer, is required.
• Experience in operating, maintaining, and troubleshooting instruments is required.
• Experience using analytical instrumentation including analytical balances, TOC, spectrophotometers, etc. is required.
• 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 with SDMS/LIMS computer system validation and reviewing data, and audit trails in Part 11 compliance systems is required.
• Experience with LCMSMS, GCMSMS, ICP-MS, qPCR Microbiological analysis and UHPLC/HPLC equipment with Empower 3 Chromatography Software is preferred.
• Experience with preventive maintenance and calibration of instruments is preferred.

Knowledge, Skills and Abilities:

• Good understanding and in-depth knowledge of cGMP, SOP's, GLP, QA/QC is required.
• Good communication skills both oral and written.
• High energy, self-motivated individual who is detail focused, organized, and able to multi-task between multiple active projects.
• Ability to work under pressure and perform tasks on schedule with minimal supervision.
• Able and willing to work in a team environment and participate in cross functional team activities.
• Able to troubleshoot instruments when needed.
• Make discretionary decisions on regular basis.
• Demonstrates strong organizational and time management skills.
• Ability to work with others and independently.
• Ability to write routine reports and correspondence.
• Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion.
• Competency to properly gown for and function within a GMP environment.
• 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 accommodations 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 accommodations 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.