Senior QC Chemist

Job Summary:

This position is responsible for the preparation processing review and release of commercial stability developmental and raw material samples within the established turnaround times in the Quality Control Laboratory. The successful candidate will organize execute and complete their daily activities in compliance with Aquestives Quality System and Quality Control Metrics.

Responsibilities:

• Performs routine testing technical data review and data release for a variety of methodologies including HPLC GC Dissolution FTIR etc. across variety of different test samples (raw material in-process/finished product stability validation development complaint etc.)
  • Prepares and standardizes laboratory reagents and test solutions.
  • Documents all work in compliance with Good Documentation Procedures.
  • Generates data reports and forms.
  • Reviews data packets for accuracy and compliance to GMP documentation practices and adherence to specifications.
  • Signs off on chromatographic data in Chromeleon Software.
  • Reviews approves and releases test results against specifications to Quality Assurance within the established turnaround times and in accordance with the product release dates provided by Quality Assurance
  • Promptly communicates with stakeholders regarding status deadlines delays and investigations.
• Prepares solutions and reviews peer solution preparation documentation for accuracy and GMP compliance.
• Actively participates and/or leads technical transfer of methods from development phase to validated phase.
• Authors and/or reviews specifications (in-process finished product raw material etc.) in Master Control.
• Routinely reviews compendia requirements for changes and/or application to internal specifications.
• Operates calibrates performs preventative maintenance and when required trouble shoots and repairs minor problems with analytical instrumentation.
• Actively participates and/or leads quality control investigations related to OOS/Event/Deviation/CAPA in partnership with peers and Quality Assurance.
  • Determine investigational plans.
  • Determines root causes for out of specification and atypical test results.
  • Develops and proposes corrective actions.
  • Supports product complaint investigations as required.
• Authors edits and reviews technical documentation (ex. reports protocols specifications SOPs SAMs Forms).
• Performs departmental tasks as assigned including sample receipt sample submission to third party laboratories DEA compliance documentation chemical inventory ordering of consumables and lab supplies disposal of waste dishwashing general lab organization and cleaning.
• Maintains regulatory compliance in instrumentation records test result documentation usage logbooks maintenance logbooks and all other product or project specific documentation.
• Performs all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.
• Works closely with others in a team environment and acts as an integral team member on multidisciplinary project teams.
• Continually reviews programs and systems to develop and drive improvements in efficiency effectiveness and quality.
• Leads hands on training for analytical techniques.
• Collates analyzes and summarizes data.
• When required interacts with internal and external auditors.
• Communicates schedule delays to the QC Coordinator.

Qualifications:

• BS/BA degree in a scientific discipline advanced degree is a plus.
• 5 years experience in a pharmaceutical analytical laboratory or regulated environment.
• Ability to handle multiple assignments and projects with competing priorities while independently managing time.
• Highly motivated self-directed detail oriented quality minded with strong organizational skills.
• Operates with a sense of urgency in a fast-paced environment.
• Ability to comprehend and follow standard operating procedures and test methods.
• Knowledgeable in general analytical techniques with working knowledge of chromatography spectroscopy and standard wet chemistry techniques.
• Effective oral and written communication skills.
• Proficient in computer use (Word Excel PowerPoint etc.).
• Strong technical writing skills.
• Able to exercise independent intellectual judgment using data driven decision making.
• Expert in working with and trouble-shooting analytical testing equipment.
• Ability to take on additional tasks as required.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities duties and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.

Required Experience:

Senior IC