Specialist Manufacturing (Quality)

Randstad Life Sciences US; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Part time

Job summary

Join a leader in pharmaceutical manufacturing as a Specialist Manufacturing (Quality) focused on maintaining and managing quality records. In this remote contract role, you will support quality assurance processes related to raw material suppliers and drive the compliance necessary for effective operations. The ideal candidate has hands-on experience in quality management systems within a fast-paced industry.

Benefits

Comprehensive benefits package

401K plan

Medical, prescription, dental, and vision insurance

Qualifications

• 3-5 years of hands-on experience managing deviations, change controls, and CAPAs.
• Strong grasp of root cause analysis and investigation review.
• Background in biotech or medical device industries preferred.

Responsibilities

• Address and close quality records related to deviation management.
• Monitor deviations owned by External Supply and implement actions.
• Provide updates and present summaries to senior management.

Skills

Quality Assurance

CAPA

Manufacturing Operations

Education

Bachelor's degree (BA / BS)

Tools

TrackWise

Veeva

Job description

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Join to apply for the Specialist Manufacturing (Quality) role at Randstad Life Sciences US

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Job Summary

Seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers.

Job Summary

Seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers.

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 Manufacturing will act as the External Supply representative across functional teams and drive 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.

location: Telecommute

job type: Contract

salary: $40.00 - 47.11 per hour

work hours: 9 to 5

education: Bachelors

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
  
  

Qualifications

• Bachelor's degree (BA / BS) or additional experience in lieu of education
• 3-5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva.
• Strong grasp of root cause analysis and investigation review is essential.
• Background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment
  
  

Preferred Qualifications

• Quality records experience specifically working with suppliers is highly desirable.
  
  

skills: Quality Assurance, CAPA, Manufacturing Operations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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