Description
Purpose and Scope Under general supervision, provides office and laboratory support to the Technical Services group in the MS&T department, which includes a variety of technical documentation activities, administrative activities, product investigation activities, and related tasks. Essential Duties & Responsibilities
- Assist with commercial process event investigations, including root cause analysis, document management, technical document review, data mining, and compiling appropriate information for timely resolution.
- Attend meetings in support of investigations, schedules, corrective/preventative action (CAPA)s, etc., as needed.
- Perform technical report and notebook reviews to ensure accuracy and completeness of documentation.
- Perform particle analysis using FTIR.
- Prepare lab instrumentation for use and assist with general particulate lab maintenance and organization.
- Change control initiation and management in Veeva document management system.
- Assist in developing special projects related to technical report generation, batch record revisions, and other process improvements.
- Assist MS&T department with preparation of proposals, meeting minutes, memos, forms, etc.
- Perform document and training updates as required utilizing Veeva.
- Create and manage purchase requisitions as needed for department(s).
- 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 other related duties as assigned.
Knowledge, Skills & Abilities
- Knowledge of the Microsoft Office Suite, including Word, PowerPoint, Outlook, Teams, OneNote, Visio, and Excel. Familiarity with warehouse management/ERP systems is preferred.
- Familiarity with statistical analysis methodology and software (JMP, MiniTab, etc.) preferred.
- Ability to develop collaborative relationships.
- Strong verbal and written communication skills.
- Ability to multi-task and adapt to changing priorities.
- Attention to details and timelines.
- Ability to work independently on assigned tasks and accept direction on given assignments.
- Must be able to work in a fast-paced, changing work environment, possess good time management skills and exhibit personal responsibility.
Core Values This position is expected to operate within the framework of Tolmar's Core Values:
- Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
- Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
- Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Education & Experience
- Associates degree or equivalent. BS/MS in scientific or engineering field preferred.
- One or more years experience working in a manufacturing, laboratory, or pharmaceutical environment preferred.
Working Conditions
- Working conditions are in an office, laboratory and manufacturing environment.
- Work may require occasional weekend and/or evening work.
- Work may require lifting objects up to 25 lbs. and the use of a respirator.
Compensation and Benefits
- Pay: $18.00 - $20.00 per hour
- Benefits: medical insurance and 401k contributions
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. Working Conditions
- Working conditions are in an office, laboratory and manufacturing environment.
- Work may require occasional weekend and/or evening work.
- Work may require lifting objects up to 25 lbs. and the use of a respirator.
Qualifications
Education
Bachelors of Chemical Engineering (preferred)
Associates of Engineering (required)
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)
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