Patient Safety Associate I (Remote-Hybrid)

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. 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

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.
• Work as an important part of the team to enhance patients' lives and make things happen.
• Be committed to Patient Safety and the patients we serve.
• Embrace change with constructive questioning and enthusiasm.
• Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency..

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
• 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

Working Conditions

PHYSICAL REQUIREMENTS

Frequent:

• 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.

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

• 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.).

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.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.