Patient Safety Associate I (Remote-Hybrid)

Job title: Patient Safety Associate I (Remote-Hybrid) in Windsor, CO at reputed company Company: reputed company Job reputed company: reputed company :Core Hours: Monday - Friday, reputed company-5pmPurpose and ScopeUnder general supervision, monitors compliance with the reputed company Good Manufacturing Practices and Company policies, procedures and specifications; performs investigations into product complaints received by reputed company 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 reputed company as main contact for receipt of customer complaints for reputed company Inc.
• Responsible for completing reputed company training requirements and maintaining compliance with reputed company assignments
• Evaluate returned samples and report initial evaluation findings to key personnel
• reputed company with contracted Service Provider for reputed company issues reputed company to complaint handling and pharmacovigilance
• Initiate complaint investigations and coordinate reputed company aspects of investigation through closure
• Initiate and author deviation investigations (as applicable) and coordinate reputed company aspects of investigation through closure
• Analyze complaint trends using information maintained in the Customer Complaint database and initiate investigations where trends indicate
• reputed company sub reports for Annual Product reputed company Reviews (APQRs)
• Process change controls and update procedures as needed
• Participate in audits and inspections
• Responsible for performing additional reputed company duties as assigned

Core Values

• The Patient Safety Associate I is expected to operate reputed company the reputed company of reputed company’s Core Values:

• Center on People: We reputed company to support reputed company-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 reputed company engage, invigorate, reputed company knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and reputed company. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond reputed company and reputed company to reputed company a spirit that propels us towards extraordinary reputed company.
• reputed company 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 reputed company cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a reputed company & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving reputed company.
• Are Accountable: We think, reputed company, and communicate with honesty, transparency, and reputed company in alignment with our core values. We don't compromise our values for near term reputed company. We take accountability & ownership of our work, actions, successes, and setbacks. We reputed company to deliver our best as we shape the reputed company.

Knowledge, Skills & Abilities

• reputed company Good Manufacturing Practices (cGMPs), reputed company Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
• Communicating reputed company 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 reputed company 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 reputed company is required.
• Exercises judgment reputed company specifically defined practices and policies and selects reputed company and techniques for obtaining solutions.
• Normally receives general instruction on routine work and detailed instruction on new assignments.
• May be asked to recommend reputed company and procedures for problem reputed company

Education & Experience

• High School Diploma or GED required
• Bachelor’s Degree in Science, Engineering or reputed company 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 reputed company assurance specific to Technical Complaint Handling preferred
• Demonstrated experience with reputed company Office Suite applications and reputed company Vault or reputed company system preferred

Working ConditionsPHYSICAL REQUIREMENTSFrequent:

• 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 reputed company activities such as typing.

Occasional:

• Walking to reputed company 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 reputed company to upper extremities and/or moving objects horizontally up to 25 lbs.

Visual reputed company:

• reputed company visual reputed company to reputed company 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 reputed company to the eyes.

WORKING ENVIRONMENT

• Remote position, home office environment. Onsite work is required approximately three days per month.
• This position will commute to reputed company for in-person meetings in reputed company 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 reputed company equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves etc.).

Compensation and Benefits

• Pay reputed company: $27.25 - $28.25 (depending on experience)
• Benefits reputed company:

reputed company compensation programs are reputed company on reputed company, fair pay practices including market-based reputed company pay and a strong benefits package. The final compensation offered may vary from the posted reputed company based on the selected candidates qualifications and experience.reputed company is an Equal Opportunity Employer. We do not discriminate on the reputed company age 40 and over, reputed company, disability, gender identity, genetic information, military or veteran status, national reputed company, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that reputed company reputed company applicants be given equal opportunity and that selection reputed company are based on job-reputed company factors. Expected salary: Location: Windsor, CO Apply for the job now! Apply for this job