Primarily would like to source role in Austin, but ok with Lake county

Schedule 8:30-5PM

Hybrid 3 days on site, flexible on days in office

Top requirements-

• Tech savvy, 3 years lap or scientific exp, CAPA exp preferred

No overtime, but mandatory if required

No relocation.

Purpose :

• Individual will work in Client’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
• Interface with internal and external 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 :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 event.
• 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.
• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.

Qualifications

List required and preferred qualifications up to 10). Include education, skills and experience.

• 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.
• A Bachelor's Degree required or 1-3 years of relevant work experience. Preferred degree in technology or scientific background (MLT, LPN, RN).
• 0-2 years’ work experience in a cGMP related industry or in a clinical setting is preferred

Job Type: Contract

Pay: $25.00 - $28.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• Day shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 3 years (Preferred)
• capa: 3 years (Preferred)
• complaints: 3 years (Preferred)
• Reporting regulations (21 CFR 803, 820 and 211): 1 year (Preferred)

Ability to Commute:

• North Chicago, IL 60064 (Required)

Work Location: In person