Specialist Manufacturing

Innova Solutions; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

Innova Solutions is seeking a Specialist Manufacturing to manage quality records and ensure compliance with regulatory requirements. Candidates should possess 3-5 years of relevant experience in the biotech or medical device industries. This full-time remote position offers a competitive hourly pay range and requires a Bachelor's degree or similar experience.

Benefits

Medical & Pharmacy Coverage

Dental/Vision Insurance

401(k) Plan

Flexible Spending Account (FSA)

Life Insurance

Short Term and Long Term Disability

Qualifications

• 3-5 years of experience in quality in biotech/medical device sectors.
• Experience with quality records related to suppliers.
• Background in project management.

Responsibilities

• Manage quality records, deviations, and CAPAs.
• Ensure compliance with regulatory agency requirements.
• Provide updates and reports to senior management.

Skills

Root Cause Analysis

Managing Deviations

Change Control

Project Management

Education

Bachelor’s Degree in relevant field

Tools

TrackWise

Veeva

Job description

3 days ago Be among the first 25 applicants

Direct message the job poster from Innova Solutions

Innova Solutions has a client that is immediately hiring a Specialist Manufacturing.

Position type: Full-time - Contract
Duration: 12 Months
Location: Remote

As a Specialist Manufacturing, you will:

Description
The manager is seeking a Quality professional to support external-facing quality records related to raw material suppliers. The ideal candidate will have 3–5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva. A strong grasp of root cause analysis and investigation review is essential. Candidates should have a background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment. Bachelor’s Degree is best but associate-degree holders with deep experience (10+ years) will be considered. B.S. + 3-5 YOE
Quality records experience working with suppliers would be a home run candidate.
Basic project management skills required.

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 Client 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

Qualified candidates shouldAPPLY NOWfor immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!
Pradip Joshi
Phone: [phone]
Email - [e-mail]

PAY RANGE AND BENEFITS:
Pay Range*: $45- $47
*Pay range 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.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
Named One of America’s Best Employers for New Grads by Forbes (2024
Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)
One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)
One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [e-mail] or [phone]. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Innova Solutions by 2x

Get notified about new Manufacturing Specialist jobs in Thousand Oaks, CA.

Thousand Oaks, CA $38.50 - $40.96 5 days ago

Thousand Oaks, CA $35.60 - $40.96 2 days ago

Camarillo, CA $120,000 - $140,000 4 months ago

Thousand Oaks, CA
$40.00
-
$47.11
5 hours ago

San Fernando, CA
$30.00
-
$35.00
2 weeks ago

Santa Clarita, CA
$28.00
-
$32.00
3 days ago

AssociateManager Manufacturing - Fitting & Weld

Proposal Manager (Defense Manufacturing)

Thousand Oaks, CA
$90,000.00
-
$110,000.00
2 days ago

Moorpark, CA
$82,300.00
-
$152,800.00
1 day ago

Santa Clarita, CA
$110,000.00
-
$110,000.00
6 hours ago

Chatsworth, CA
$89,000.00
-
$147,000.00
1 week ago

Camarillo, CA
$80,000.00
-
$120,000.00
2 weeks ago

Specialist QA Drug Product - Thousand Oaks, CA

Supply Chain Manufacturing Operational Excellence TPM/IWS - Manager - Consulting - Location OPEN

Westlake Village, CA
$127,100.00
-
$233,000.00
2 days ago

Santa Clarita, CA
$110,000.00
-
$125,000.00
15 hours ago

Manufacturing Engineer ( Medical Device )

San Fernando, CA
$25.48
-
$45.00
1 month ago

Senior Manager Manufacturing Systems (Drug Substance Automation)

Customer Operations Specialist (On-Site)

Santa Clarita, CA $68,640 - $77,000 5 days ago

Specialist, Quality Assurance Planning Engineer - Special Process 1

Camarillo, CA $81,266 - $131,131 2 weeks ago

Fuel Injector Rebuilder Apprentice (Manufacturing/Automotive)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.