Description
Pharmaceutical QA Specialist II / Product Complaint Analyst positions available with a Major Pharmaceutical Company based in the Waukegan / North Chicago, IL area!! Apply now with Luke H. at A-Line!!
Pay Rate $22 - $26 hourly (determined on experience)
Work Schedule: Mon-Fri 8am-4:30/5pm CST (we do have the option to work remotely. Currently it is not a set number of days but flexible)
Job Summary:
- Individual will work in the company's 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 company 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.
- Cubicle environment, individual role - this role requires sitting at a computer for long periods of time, candidate must be comfortable in that type of environment.
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, company functional areas and regulatory agencies.
Qualifications:
- 1 year quality and/or complaint handling experience. 3-5 years quality and/or complaint handling experience highly preferred!
- Microsoft Excel Knowledge and Experience - sorting, filtering are a must
- Self-starter/independent worker and adaptive to change while taking initiative to improve/create efficiency
- 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 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
Why Apply with A-Line?
- Full benefits available after 90 days: Medical, Dental, Vision, Life, Short-term Disability
- 401k after 1 year of employment: With employer match and profit sharing
- GREAT Hours! Monday through Friday, 40 hours per week
- Competitive Pay Rate!
Keywords: QM, Quality Assurance, Quality Control, Quality Management, GMP, Global Regulatory Requirements, Good Documentation Practice, Pharmaceutical, Biotech, Biopharmaceutical, QMS, Quality Management System, Medical Device, MDR, Medical Device Regulations, Medical Device Reporting, FDA, Complaint Resolution, GDP, GCP, CMC, QC, QA, Pharma, Biotech, Quality Systems, Complaint, pharmaceutical products, Technical Writer, Documentation Management, Medical Writing, Clinical Research, Regulatory Affairs, Regulatory Compliance, Quality Assurance, Clinical, Pharmaceutical, Quality Control, Medical Writing, Clinical Regulatory documents, Trial Master File, TMF, ICH, GCP Guidelines.
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