Global Product Surveillance Quality Associate II - Planet Pharma : Job Details

Job DescriptionTarget Pay Rate: 24/hr salary will be commensurate with experience Job Description: This section focuses on the main purpose of the job in one to four sentences. This position is responsible for complaint handling, will triage incoming complaints for the assigned team, and will process all levels of complaints without supervision. Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

• Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
• Collect necessary complaint information for investigations.
• Determine reportability of a complaint.
• Respond to customer complaints (written or verbal) and write technical investigation response letters.
• Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams).
• May lead projects as assigned by management.
• May have technical approver responsibilities.
• Manage workflow; identify and escalate issues.
• Participate in mentoring and training of the Product Surveillance team.
• Ability to perform all duties required of previous levels.

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• List knowledge, skills, and/or abilities required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
• Understanding of the products intended use and manufacturing process of assigned products.
• Strong technical writing skills, able to review complaint investigations and write customer response letters.
• Readily accepting of assignments to new/ different products.
• Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
• Excellent written/verbal communication and organizational skills.
• Ability to make independent decisions with minimum oversight.
• Strong problem solving and analytical skills.
• Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.

Education and/or Experience:

• Bachelors degree required.
• 2-5 years relevant work experience in cGMP related industry or in a clinical setting.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.