Specialist Quality Complaints , Biopharma - Remote (JP12212)
Location
Thousand Oaks, CA | United States
Job description
Job Title: Specialist Quality Complaints, Biopharma – Remote (JP12212)
Location: Thousand Oaks, CA. 91320
Business Unit: Electro-Mechanical Complaints
Employment Type: Contract
Duration: 6 months with possible extensions or conversion to permanent
Rate : $42 - $45/hour W2
Posting Date: 2/13/24
Notes: Only qualified candidates need apply.
3 Key Consulting is recruiting a
Specialist Quality Complaints for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description: The Complaints Specialist will investigate complaints, lead cross-functional teams to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine 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.
Top Must Have Skill Sets: - Years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field - Ability to oversee multiple projects simultaneously.
- Ability to successfully manage workload to timeliness.
- Candidates can actually talk through about their relevant skill sets and convey their experience eloquently.
Day to Day Responsibilities: - Reviewing and acknowledging information contained in product complaint records.
- Determining if additional information is required to assign appropriate investigation requirements .
- Determining if return samples are required and following its status .
- Reviewing and approving assessments supporting the investigation .
- Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event .
- Completing historical data analysis and trend evaluation assessments
- Voiding records if required .
- Completing customer feedback records if required
- Own consolidated/trend investigations until closure, if required
Basic Qualifications: Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Why is the Position Open? Supplement additional workload on team
Red Flags: Not proficient on the following requirements:
- Ensures quality of complaint records, consolidated / trend investigations.
- 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.
- Follows procedures and regulatory requirements.
Interview Process: TBD/ WebEx
We invite qualified candidates to send your resume to
[email protected] . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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