Quality Systems Specialist

The Opportunity:

At Avantor, people are the most important part of our success because they drive our global performance. That’s why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor’s Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits

The Quality Systems Specialist is responsible for maintaining policies and procedures according to applicable regulatory requirements. Familiarity with regulated industries and basic concepts related to applicable regulations and standards (ISO 9001, AS9100, ISO 13485, cGMP).

Development and oversight of standard operating procedures for compliance processes. This position is responsible for supporting compliance audits internally, externally as well as all customer and regulatory audits. The appropriate candidate must be highly adaptable, detail-oriented, work well under minimal supervision, and effective problem-solving skills.

This position reports to the QA Manager and reports into our Bakersfield, CA Nusil Location

Who you are:

• Education: Bachelor's degree or equivalent from four-year college or technical school; or two years of experience in QA at an ISO registered company; or equivalent combination of education and experience.
• Experience: two years of experience in QA at an ISO registered company; or
• Must be computer literate and experience with the Microsoft Office Suite (Word, Excel, Outlook, Power Point). Agile experience a plus.
  
  

Who you are:

• Ability to read, analyze, and interpret general business documentation, and technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedural manuals.
• Possess a basic understanding of statistics and group metrics as applied to business performance measurement using resources such as Microsoft Excel.
• Capable of performing situational and problem analysis of business systems and processes.
• Draw logical practical conclusions from that analysis.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The behavioral demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
• Optimally handle and prioritize multiple tasks, concentrate on work while surrounded by distractions, and work as a team player.
• Able to receive, comprehend and follow complex oral and written instructions from supervisory and/or management staff.
• Be able work independently (under limited supervision), meet deadlines, and communicate and give complex oral and/or written instructions.
• Friendly, positive attitude and dependable attendance.
  
  

How you will create an impact:

• Responsible for coordinating and independently managing projects.
• Provides information, support, and guidance to team within the scope of the functional unit.
• Assists with training/cross-training department personnel in area of specialty.
• Serves as a temporary backup to department personnel if the need is determined by supervisor.
• May lead meetings of cross-functional teams related to projects.
• May assist in analyzing and improving department and functional unit procedure and policy.
• Responsible for electronic data entry as well as updating and distribution of QA forms.
• Assists with generation and maintenance of quality documentation.
• May assist with material release functions that require focused attention to detail.
• May assist with movement of released material and product disposition documentation.
• May generate variance reports or other product-related reports.
• May generate, review, or revise controlled documentation.
• May edit and update various procedures and policies.
• Participate and contribute to ISO 9001 audits and assist with ISO 9001 program documentation and implementation. Host customer and certifying body audits. Perform external provider/supplier audits.
• May act independently as the Qualified Person for product disposition, release or reject. Responsible for ensuring that each individual batch has been manufactured and tested in accordance with defined release procedures.
• Interacts with various departments in communicating QA standards.
• Must be regular and punctual in attendance
• Responsible for maintaining quality within the scope of the job description.
• Assists in training of department personnel.
  
  

What’s the environment like?

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee must be able to work in non-climate-controlled areas. The noise level in the work environment is usually moderate
• For safety, the use of contact lenses for any reason, cosmetic or corrective, is prohibited on the production floor, in the lab areas, in the engineering shop, or while working on equipment.
• The company will provide prescription safety glasses with a current (under 12 months) vision corrective prescription provided by the employee.
• While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk and hear.
• The employee is regularly required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  
  

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000 associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

$58,000.00 - $97,000.00

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.