Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding 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, general 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.
Top 3-5 skills, experience or education required for this position:
M-F 8-4:30/5
A Bachelor 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.
1 year quality and/or complaint handling experience.
Degree 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent, this role requires sitting at a computer for long periods of time, candidate must be comfortable in that type of environment
Required Skill 1: Detail orientedRequired Skill 2: Microsoft Excel Knowledge and Experience – sorting, filtering are a mustRequired Skill 3: Adaptive to changeRequired Skill 4: Self-starter/independent workerRequired Skill 5: Taking initiative to improve/create efficiencyAbout US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
