29665 Specialist Quality Complaints - Pharma/Biotech Processes

EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelor’s degree in Sciences & 5 years of investigation experience.
The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
Key Responsibilities:
Ensures quality of complaint records
Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
Executes against prioritized work plans
Quickly escalates issues that could impede the ability to close records according to action plans
Maintains compliance with local and global processes
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter expert assessments
Escalates potential Quality issues to Management

AVAILABILITY:
ADMINISTRATIVE SHIFT AND NON-STANDARD SHIFT
Job Type: Contract
Salary: $28.00 to $32.00 /hour
Experience:
Audit Batch Record: 1 year (Preferred)
Pharma/Biotech investigations: 5 years (Required)
Pharma Quality: 1 year (Preferred)
Quality of complaint records: 1 year (Preferred)
Audit Pharma/Biotech processes: 1 year (Preferred)

Location:
Juncos, PR 00777 (Required)

Language:
English and Spanish (Required)

Contract Length:
5 - 6 months

Contract Renewal:
Likely

Benefits:
None

Typical start time:
8AM

Typical end time:
5PM

Pay Frequency:
Bi weekly or Twice monthly

This Job Is:
A job for which all ages, including older job seekers, are encouraged to apply

Schedule:
Monday to Friday
Other

Work Remotely:
Temporarily due to COVID-19