Company: Tolmar
Job description: Description :Core Hours: Monday - Friday, 8am-5pmPurpose and ScopeUnder general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications; performs investigations into product complaints received by Tolmar Inc. Occasional onsite work is required approximately three days per month.Essential Duties & Responsibilities
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws
- Maintain the Technical Complaint System and database and act as main contact for receipt of customer complaints for Tolmar Inc.
- Responsible for completing all training requirements and maintaining compliance with all assignments
- Evaluate returned samples and report initial evaluation findings to key personnel
- Interact with contracted Service Provider for all issues related to complaint handling and pharmacovigilance
- Initiate complaint investigations and coordinate all aspects of investigation through closure
- Initiate and author deviation investigations (as applicable) and coordinate all aspects of investigation through closure
- Analyze complaint trends using information maintained in the Customer Complaint database and initiate investigations where trends indicate
- Provide sub reports for Annual Product Quality Reviews (APQRs)
- Process change controls and update procedures as needed
- Participate in audits and inspections
- Responsible for performing additional related duties as assigned
- The Patient Safety Associate I 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.
- Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
- Communicating clearly and concisely, both orally and in writing.
- Excellent troubleshooting and problem solving skills.
- Business, scientific and personal computer hardware and software applications.
- Independent, organized, and able to schedule work without supervision to meet schedule deadlines.
- Establishing and maintaining cooperative working relationships with others
- Ability to coordinate activities to assure customer needs are met.
- Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
- Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
- Normally receives general instruction on routine work and detailed instruction on new assignments.
- May be asked to recommend methods and procedures for problem resolution
- High School Diploma or GED required
- Bachelor’s Degree in Science, Engineering or related field from an accredited college or university preferred; or an equivalent combination of education and/or experience
- Two or more years of experience in the pharmaceutical or medical device industry
- Experience in quality assurance specific to Technical Complaint Handling preferred
- Demonstrated experience with Microsoft Office Suite applications and Veeva Vault or related system preferred
- Sitting for extended periods of time at work station or mobile equipment
- Repetitive Motions (frequent motions of the wrists, hands and/or fingers). Using fingers to perform activities such as typing.
- Walking to move short distances quickly and frequently
- Twisting/Reaching – turning at waist and extending hands and/or arms in any direction
- Grasping – applying pressure to an object with the fingers and palm
- Lifting and raising from lower to upper extremities and/or moving objects horizontally up to 25 lbs.
- Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects and/or small parts including inspection of complaint samples, using assembly at a distance close to the eyes.
- Remote position, home office environment. Onsite work is required approximately three days per month.
- This position will commute to Tolmar for in-person meetings in Fort Collins or Windsor approximately two (2) times per year or as required.
- Complaint sample evaluations: limited exposure to fumes or odors. May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves etc.).
- Pay rate: $27.25 - $28.25 (depending on experience)
- Benefits summary:
Expected salary:
Location: Windsor, CO
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