QC Assoc Lead Analyst (Onsite)

at  TOLMAR Inc

CORE VALUES

• The QC Associate Lead Analyst is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor’s degree in Science required, preferably in chemistry or biochemistry.
• Three or more years of experience in an analytical laboratory environment with at least one year in a pharmaceutical GMP setting.

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

Knowledge, Skills & Abilities

• Intermediate knowledge in analytical testing of drug substances and formulations.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Some knowledge in analytical method validation, analytical troubleshooting, product investigation and instrument qualification.
• Intermediate knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Experience in the use of USP, NF and other compendia.
• Ability to solve complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers

PURPOSE AND SCOPE

The QC Associate Lead Analyst will assist the Lead Analysts and QC Management in providing training, technical assistance, and SME-level support for a team of testing analysts that provide customer service to the Tolmar supply chain. This position is for individuals interested in the management track development.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Facilitate testing and release of Tolmar products, cleaning samples, raw materials, and stability samples.
• Coordinate laboratory activities to assure customer needs are met in terms of sample analysis cycle time.
• Serve as a technical resource for GMP requirements and testing processes.
• Support development or revision of procedures and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance.
• Assist in the performance of lab investigations and root cause analyses. Complete minor deviations. Assist in the Identification and complete CAPA and Effectiveness checks.
• Gain knowledge in instrument troubleshooting and qualification processes.
• Provide technical expertise for document updates (procedures) and review within the QC department. Upon delegation, may have the technical authority for review and approval of such documents in EQMS.
• Prioritize projects to meet timelines.
• Perform responsibilities under minimal supervision and support Lead Analysts and departmental management in all aspects of organizational functions.
• Mentor others in the department to ensure department maintains high standards for quality of work.
• Contributes to cost savings and efficiency projects where appropriate.
• Participate in company and department meetings, third party audits, and regulatory audits.
• Assist Lead Analysts and management in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills and regulatory expertise.
• Make scientific recommendations to management and other departments regarding Quality Control laboratory protocol.
• Participate in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Maintain compliance with all Tolmar health and safety policies, as well as OSHA standards.
• 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.

  Knowledge, Skills & Abilities

• Intermediate knowledge in analytical testing of drug substances and formulations.

• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Some knowledge in analytical method validation, analytical troubleshooting, product investigation and instrument qualification.
• Intermediate knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Experience in the use of USP, NF and other compendia.
• Ability to solve complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.