Product Complaint Analyst in North Chicago, IL

Hybrid role (3 days onsite, 2 days ), flexible on days

PhD candidates can apply if they are comfortable with rate offered

Open for candidates who are ready to relocate at their own expense

• Pharmacovigilance background will not work for this role
• GMP exp is the key
• Pharma or medical device industry exp needed
• Good communication skills
• Manage product complaint records in the electronic system, determining investigation needs, leading activities, and documenting reports.
• Product complaint for investigational drugs and devices
• Gather complaint information by interfacing with external clinical investigators and partner companies.
• Bachelors degree in life science or equivalent experience
• Masters degree will be considered
• Biology or chemistry degree with 5 yrs exp will work
• Minimum 3 yrs exp needed\

Top skills

• Exp with investigations
• Pharma or medical device QA exp
• product complaints
• Communication

Job Description:

• In this role, you will initiate and manage product complaint records in the electronic system, determining investigation needs, leading activities, and documenting reports.
• You will gather complaint information by interfacing with external clinical investigators and partner companies.
• You will work with manufacturing and quality engineering to conduct investigations and implement CAPAs as needed.
• You will assess the risk and impact of complaints on clinical supplies and liaise with Post Marketing Quality to evaluate the reportability of complaints to regulatory agencies.
• Additionally, you will ensure consistency between product complaints and adverse event information in collaboration with safety organizations.

Experience/Skills:

• Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
• 3+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
• Proven organizational skills.
• Effective use of oral and written communication skills.
• Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.

Responsibilities include:

• Initiating and managing product complaint records; assessing the risk of complaints to patient safety and quality of clinical supplies; determining investigation needs for complaints; leading investigative activities across functional areas; gathering complaint information from clinical investigators and external partners; collaborating with partner companies on complaints.

What are the top 3-5 skills, experience or education required for this position:

1. Analytical and investigative mindset
2. Strong oral and written communication skills
3. Effective organizational abilities; comfortable with multitasking.

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