Manufacturing Specialist

Aditi Consulting; Thousand Oaks (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Aditi Consulting is seeking an Entry Level Manufacturing Specialist to manage quality records and ensure compliance within the biotech industry. This role involves investigating deviations, implementing corrective actions, and presenting comprehensive updates to senior management, with a competitive hourly pay range.

Benefits

Medical benefits

Dental benefits

Vision benefits

401(k) plan participation

10 paid days off

Commuter benefits

Life and disability insurance

Qualifications

• Quality record owner experience required.
• Basic knowledge of Veeva or Trackwise preferred.
• Experience in the biotech industry is necessary.

Responsibilities

• Address and close quality records under the company's quality management procedures.
• Monitor deviations and implement corrective actions.
• Build quality records summaries for senior management review.

Skills

Quality record owner experience

Basic knowledge of Veeva

Basic knowledge of Trackwise

Biotech industry experience

Job description

This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$38.50/hr - $40.96/hr

Payrate: $38.50- $40.96/hr.

Summary:
The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist will act as the External Supply representative across functional teams and drive the closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the Company network.

Responsibilities:

• Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.
• Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
• Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management

Top 3 Must Have Skill Sets:
1. Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
2. Basic knowledge of Veeva or Trackwise
3. Biotech industry experience

Pay Transparency: The typical base pay for this role across the U.S. is: $38.50- $40.96/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.

#AditiConsulting

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Management and Manufacturing

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