Senior QC Analyst (2nd Shift; Tues - Sat)

About the role

Performs complex testing of raw materials, bulk intermediate and finished products, and stability samples, according to established regulatory protocols and procedures, in support of manufacturing.

Responsibilities

• Expertise in performing analyses on a variety of samples using advanced preparation techniques and analysis methods.
• Expertise with basic and intermediate techniques and analysis methods.
• Provide mentorship to QC analyst in all aspects of analyses performed within the QC chemistry laboratory including but not limited to documentation, procedures, and regulations.
• Document all activities and maintain records according to good documentation practices.
• Ensure proper use, care, maintenance, and troubleshooting of instrumentation.
• Perform high-level method transfers. Guide the department in the evaluation and implementation of new technologies.
• Provide detailed accounts of testing performed to investigators. Perform investigational testing as directed by a primary investigator.
• Make scientific recommendations to management/technical writers regarding QC procedures.
• Able to take recommendations and incorporate those recommendations into a document to ensure the appropriate changes are made.
• Act as a technical reviewer for document updates to ensure changes that are made are justified and scientifically sound.
• Route documents in the electronic document control system to ensure document updates are routed promptly and correctly.
• Complete tasks on time and with minimal errors.
• Follow all procedures applicable to job functions to ensure high quality of work.
• Mentor others in the department to ensure department maintains high standards for quality of work.
• Prioritize tasks and perform job duties with minimal guidance from management.
• Contribute to a highly productive environment by avoiding distractions.
• Ensure compliance with company and regulatory data integrity guidelines.
• Participate in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings.
• Respond to spills per company procedures.
• Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
• Support adherence to department budget by identifying alternative cost-saving and compliant materials and equipment, where appropriate.
• Represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary.
• May provide technical expertise to determine root cause of aberrant method transfer results.
• Interact respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning.
• Appropriately resolves differences of opinion.
• Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.
• Lead implementation of change and escalate issues as necessary.
• Identify issues and possible solutions and escalate those issues and solutions to the department senior leadership or management as appropriate.
• Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts.
• Generate new ideas to create efficiencies and improve processes; willingly support new ideas and process enhancements.
• Understand and process complex information and exercise sound judgment, considering the situation, the issues, the key players and the levels of authority involved.
• Propose courses of action that further the objectives, priorities, and vision of the organization; see "big picture."
• Perform additional duties as assigned.

Qualifications

• Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Six or more years of experience in an analytical laboratory position using advanced techniques and demonstrated proficiency with complex testing.

Skills

• Advanced knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
• Advanced knowledge in the use of USP, NF and other compendia.
• Highly proficient use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
• Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Effective written and oral communication skills.
• Ability to interpret, understand and follow analytical procedures and calculations.
• Demonstration of training and project leadership skills.
• Expert knowledge in analytical testing of drug substances and formulations.

Benefits

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Pay

$47.00 - $50.00 depending on experience

Shift differential

18%

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.