Quality Complaints Specialist Jobs

Job Title: Specialist Quality Complaints

Duration: 12 months (potential to extend)

Location: Remote

Description:

Accountable 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.

Key Responsibilities

• Ensures quality of complaint records

• Applies analytical skills to evaluate complex situations using multiple sources of information.

• 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.

Authority

• Owns complex quality record content.

• Determines situations which require escalation to management.

• Determines when a complaint dictates further investigation.

• Works under minimal direction

• Proposes revisions to SOPs in area of responsibility.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree & 2 years of directly related experience OR

• Bachelor’s degree & 4 years of directly related experience OR

• Associate degree & 10 years of directly related experience OR

• High school diploma / GED & 12 years of directly related experience.

Preferred Qualifications:

• 4+ 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 timelines.

• Familiarity with basic project management tools

• Ability to negotiate a position after taking feedback from multiple sources.

• Demonstrated ability to consistently deliver on-time, and high-quality results.

• Ability to operate in a matrixed or team environment.

• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Top 3 Must Have Skill Sets:

• Investigative background/ process based in complaint records

• Ability to manage multiple projects • Ability to communicate and interact in a crossfunctional environment

Compensation, Benefits and Ancillaries Compensation

This is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position $___41__ - $___45__ (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Thanks & Regards,

Chenchukala Alwar

Senior Technical Recruiter

C: 650-376-0819

www.aditiconsulting.com

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