QC Analyst II (Onsite) - 3rd Shift (Sunday - Thursday)

Purpose and Scope

Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and procedures.

Essential Duties & Responsibilities

• Prioritizes tasks and performs job duties with minimal guidance from management.
• Works to complete tasks in an efficient manner, and is a productive member of the department.
• Performs analyses on a variety of samples using intermediate preparation techniques and analysis methods.
• Becomes proficient in the intermediate preparation techniques and analysis methods.
• Contributes to short-term team objectives, focusing on routine tasks while ensuring consistency and quality.
• Develops and implements strategies to overcome daily challenges and improve workflows.
• Applies intermediate technical skills and a foundational understanding of cGMP, organizational structure, and departmental processes to complete standard work assignments.
• Demonstrates a continuous improvement mindset by taking the initiative to support projects.
• Delivers high-quality work on a consistent basis, meeting deadlines and maintaining reliability in daily tasks.
• Proactively develops actionable solutions based on an understanding of the problem, collaborating with team members when necessary to ensure the solution is effective and aligns with organizational goals and regulatory requirements.
• Maintains focus and concentration to complete tasks with minimal mistakes, maintaining quality under pressure, and ensuring focus during work to support infrequent preventable errors.
• Takes responsibility for individual contributions and accepts accountability for performance.
• Participates in team activities, challenges, and shared responsibilities (such as T-cards, archival, etc.), showing enthusiasm and a can-do attitude to inspire others, while maintaining professionalism.
• Overcomes challenges with a positive attitude, staying focused on the goal even in the face of setbacks.
• Maintains a clean, orderly and safe work environment and proactively restocks low inventory items and routine lab supplies.
• Trains junior analysts in analysis methods and lab techniques.
• Documents all activities and maintains records according to good documentation practices.
• Maintains an atmosphere of teamwork, cordiality and respect towards co-workers and is willing to assist co-workers in the completion of tasks.
• Represents the department by providing accounts of testing performed and results of method transfer activities and assists with troubleshooting aberrant method transfer results, if necessary.
• Interacts respectfully with all other employees both inside and outside of the department and members of management and shows interest in others' input and reasoning.
• Identifies issues and escalates those issues to the department senior leadership or management as appropriate.
• Participates in required annual hazardous waste training.
• Responds to spills per the Chemical Spill Procedures.
• Completes tasks on time and works to eliminate repeat errors.
• Follows all procedures applicable to job functions to ensure high quality of work.
• Ensures that company and regulatory data integrity guidelines are consistently followed.
• Completes intermediate method transfers.
• Provides detailed accounts of testing performed to investigators.
• Under the direct supervision of an investigator, may perform investigational testing.
• Makes scientific recommendations to management/technical writers regarding QC procedures.
• Completes additional duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of a government regulated pharmaceutical laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
• Intermediate understanding of the use of USP, NF and other compendia.
• Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, Dissolution and UV-Vis spectrophotometers.
• Effective written and oral communication skills.
• Knowledge of computer systems for sample tracking, laboratory equipment, chromatography, raw data handling and storage.
• Ability to interpret, understand and follow analytical procedures/calculations and scientific principles.

Core Values

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Are Proactive & Agile: Engage, act, adapt to change, respond swiftly and efficiently to ignite a spirit that propels the organization towards extraordinary outcomes.
• Act Ethically: Conduct business ethically, compliantly, and socially aware, in line with the purpose of positively impacting lives. Cultivate diversity, equity, inclusion & sustainability in the workplace.
• Constantly Improve: Enhance products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. Embrace calculated risk-taking that drives better ways of working.
• Are Accountable: Deliver the best, thinking, acting, and communicating with honesty, transparency, and clarity in alignment with core values. Don't compromise values for near-term gain. Take accountability & ownership of work, actions, successes, and setbacks.

Education & Experience

• Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Two or more years of experience in a QC analytical laboratory position in the pharmaceutical industry.
• Experience with chromatography software.

Compensation And Benefits

• Pay: $36.00 - $37.00 per hour, depending on experience.
• 20% shift differential applicable after training period.
• Benefits summary: https://www.tolmar.com/careers/employee-benefits.

Additional Information

• Tolmar is an Equal Opportunity Employer.
• We do not discriminate on the basis of 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.