QC Analyst II (Onsite)

at  TOLMAR Inc

KNOWLEDGE, SKILLS & ABILITIES

• Knowledge of a government regulated 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, and UV-Vis spectrophotometers.
• Effective written and oral communication skills.
• Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Ability to interpret, understand and follow analytical procedures/calculations and scientific principles.

EDUCATION

Required

• Bachelors or better in Chemistry or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c

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

• Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods. Employee will be trained and become proficient in the intermediate preparation techniques and analysis methods.
• At the direction of management, train junior analysts in analysis methods and lab techniques.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care and maintenance of instrumentation.
• Perform intermediate method transfers.
• Provide detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing.
• Make scientific recommendations to management/technical writers regarding QC procedures.
• Completes tasks on time and works to eliminate repeat errors. Follows all procedures applicable to job functions to ensure high quality of work.
• 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. Contributes to a highly productive environment by avoiding distractions.
• Employee is responsible for ensuring that company and regulatory data integrity guidelines are consistently followed.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Willing to assist co-workers in the completion of tasks.
• Will represent the department by providing accounts and results of method transfer activities and assist 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. Appropriately resolves differences of opinion.
• Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.
• Identifies issues and escalates those issues 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. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform additional duties as assigned.