What are the responsibilities and job description for the QA Specialist / Product Complaint Analyst (Pharma/Medical Device) position at Systems Ally?
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
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: $26.00 - $28.00 per hour
Expected hours: 40 per week
Benefits:
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- Quality Assurance: 2 years (Preferred)
- product complaint: 2 years (Preferred)
- pharma or medical device industry: 2 years (Preferred)
- CGMP: 1 year (Preferred)
- Knowledge of FDA requirements for Quality Systems: 2 years (Preferred)
Ability to Commute:
- North Chicago, IL 60064 (Required)
Work Location: In person
Salary : $26 - $28
