Patient Safety Associate I (Remote-Hybrid) in Windsor, CO

Patient Safety Associate I (Remote-Hybrid) - Tolmar - Windsor, CO - work from home job Company: Tolmar Job description: Description : Purpose and Scope Under 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. The temporary assignment requires being onsite four continuous hours up to three times per month. The duration of this assignment is through October 2023. 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.
• 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.
• Responsible for performing additional related duties as assigned.

Core Values

• The Patient Safety Associate I 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.

Knowledge, Skills & Abilities

• 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.

Problem Solving:

• 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

Education & Experience

• 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.
• Experience in the pharmaceutical or medical device industry in quality assurance including experience specific to Technical Complaint Handling preferred.

Compensation and Benefits

• Pay rate: $26.00 - $28.00 (depending on experience)
• Benefits summary:

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 PHYSICAL REQUIREMENTS Frequent:

• Sitting for extended periods of time at workstation or mobile equipment.
• Repetitive Motions (frequent motions of the wrists, hands and/or fingers). Using fingers to perform activities such as typing.

Occasional:

• 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.

Visual Acuity:

• 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.

WORKING ENVIRONMENT

• Conditions are normal for an office environment.
• 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.).

Tolmar is an Equal Opportunity Employer.