Individual will work in Client’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
Interface with internal client’s customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, public, manufacturing sites, technical support, commercial organization, and PV regarding client’s product complaints.
Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.
Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities:
Assure complaint records meet global requirements.
Product complaint documentation, investigation, and review of all non-medical complaint content.
Responsible for reviewing medical complaints that involve a non-medical quality related problem.
Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing, and good documentation. Responsible that complaint files meet all regulatory requirements.
Identification of potentially reportable events and notification to appropriate functional groups and management.
Interface with Third Party Manufacturers, health care professionals, public, internal customers, functional areas and regulatory agencies.
Qualifications:
Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
Solid written/verbal communication and organizational skills.
Knowledge and application of computer systems for word processing and complaint management.
Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Education:
A bachelor’s degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
0-3 years’ work experience in a cGMP related industry or in a clinical setting is preferred.
Years of experience/education and/or certifications required: 1 year quality and/or complaint handling experience.
What are the top 3-5 skills requirements should this person have?
Detail oriented
Microsoft Excel Knowledge and Experience – sorting, filtering are a must
Adaptive to change
Self-starter/independent worker
Taking initiative to improve/create efficiency
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Degree is preferred
3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $25.00/hr.
