QA Specialist /Product Complaint Analyst in North Chicago, IL

Position Title: QA Specialist II/Product Complaint Analyst I

Length of Contract: 6 months

Location/Site: US-IL-Lake County

Remote, 100% Onsite, or Hybrid Onsite Schedule: 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 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 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, Client 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

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