Position Title: Product Complaint Analyst Length of Contract: 6 months (Potential Extension) Location/Site: 60064, North Chicago, IL
Hybrid model 3 day in the office – 2 days WFH. Currently it is not a set number of days but flexible
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, general 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, general public, internal customers, AbbVie 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.
What hours and days will this person be working? 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.
Top 5 skills/requirements Required Skill 1: Detail oriented Required Skill 2: Microsoft Excel Knowledge and Experience – sorting, filtering are a must Required Skill 3: Adaptive to change Required Skill 4: Self-starter/independent worker Required Skill 5: Taking initiative to improve/create efficiency
What years of experience, education, and/or certification is required? 1 year quality and/or complaint handling experience. Degree. What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent. What is the environment that this person will be working in (i.e. group setting vs individual role)? Cubicle environment, individual role Is any testing required for this role? None this role requires sitting at a computer for long periods of time, candidate must be comfortable in that type of environment
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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $29.00/hr.
