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Quality Assurance Supervisor

Scantibodies Biologics El Cajon, CA
  • Depends on experience
  • Exempt
  • Health Insurance, 401K / Retirement, Dental Insurance, Employee Discounts, Vision Insurance
  • Employer Unlikely to Respond

Summary:

The objective of the position is to ensure that Scantibodies Biologics’ plasma collection centers operate in compliance with all quality assurance and regulatory requirements.  The person in this position is a key driver of change within Scantibodies and is heavily focused on improvements in the Scantibodies Biologics center activities to yield world-class quality, compliance, and operational efficiency.

Essential Duties:

Research source plasma collection regulations

Review and approval of all Scantibodies Biologics’ center procedures

Establish and lead compliance committees

Write quality system procedures for source plasma collection centers

Guides, reviews, and approves validation protocols for source plasma collection centers

Trains personnel on quality tools and quality systems

Responsible for ensuring the timely performance reviews of staff.

Analyzes plasma center data to develop improvement initiatives

Audits plasma centers to ensure compliance with regulations and procedures and tracks the completion of corrective actions

Submits regulatory submissions to the FDA to maintain licenses

Represents regulatory and quality during FDA inspections of all source plasma collection centers

Supervises quality and regulatory personnel at the plasma collection center

Travels to source plasma collection centers on a regular basis throughout the country (currently only 1 center in El Cajon, CA)

Equipment Used:

Personal Computer

General Office Equipment

Job Specifications:

High school diploma or equivalent.  Bachelor’s degree preferred or equivalent work experience

Work skills and experience required:

  1. Must have a minimum of 5 years of experience in quality, regulatory compliance or an equivalent related field.
  2. Must have a minimum of 3 years of supervisory experience in quality, regulatory compliance or an equivalent related field.
  3. Must be computer literate in office applications such as MSWord and Excel
  4. Must possess excellent communication, interpersonal, and analytical skills, both written and oral and be able to conduct presentations for all levels of employees and management. Interpersonal and analytical skills should extend into areas of personnel development and coaching as it applies to quality tools and methods.
  5. Must work well in team environments and must be self-motivated.

The following characteristics are important for success;

-Strong team leadership skills; will lead by example and be willing to pitch in to get the job done.

-Credibility with subordinates, senior management, business partners, relevant agencies and customers.

-A bias for action;  effectively develops and executes strategies and plans; demonstrates a track record of achievement.

-Excellent strategic thinking, including the ability to help define the direction of the laboratory and manufacturing organization in support of company objectives and make the appropriate business decisions to get there.

-A comfort level with challenging others and having your own ideas challenged.

-The ability to set the highest standards of achievement and capable of assisting others to realize the same.

-The ability to set and adhere to the highest level of integrity, morals and ethics.

-A high degree of professionalism with the ability to be a high energy, passionate champion for the company.

-An ability to build closely-knit teams and interacting effectively across disciplines.

-Sensitivity to customer requirements.

-Develop and execute the laboratory and manufacturing operations strategy commensurate with the overall plan for the company.  Ensure alignment with customer needs.

-Implement continuous improvement initiatives to drive operations and ensure maximum productivity.  Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.

 -Develop and implement policies and programs designed to maximize capacity and ensure the highest quality at the lowest cost in a safe working environment.

-Develop and apply appropriate metrics for laboratory and manufacturing goals and objectives in terms of production output, cost, quality, budgeting and forecasting, as well as, the ongoing results of continuous improvement initiatives.

-Create an organization that is flexible and adaptable with the ability to efficiently handle new science and technologies.

-Provide leadership to the laboratory and manufacturing organization to ensure that teamwork and morale are a fundamental component of world-class output.  Create active development plans for the staff.

-Ensure processes are in place to allow transparency of laboratory and manufacturing metrics through management to the QMR team.

-Adhere to all GMP and ISO guidelines.

-To stay in close communication with subordinates and senior management to be available after hours, weekends, and holidays for contact.

-Return all phone calls as soon as possible and certainly within the same day. On the rare occasion that you are unable to return a call for some dire reason then call no later than first thing the following morning.  To keep your cell phone with you and turned on.

-Any time you are unable to report to work due to illness you must speak directly to the Director, QA/RA, if that person is not available then to Human Resources.  It is not acceptable to leave voice mails, e-mails or messages with co-workers. 

-To leave contact information with the Director, QA/RA and Human Resources when on vacation in the event you must be contacted.

Working Conditions/Physical & Mental Demands:

Laboratory and office environment.

Internal routine activities require the ability to understand and work with abstract concepts and express them in more concrete terms for staff and others.  A large percentage of the problems encountered are unique in nature, requiring creativity and innovation for effective resolution.  Assessment of problem situations often requires assimilation of inputs from various (and sometimes conflicting) sources.  Analysis of information entails use of complex analytical skills.

Supervision of Others:

Supervises quality, regulatory, and compliance personnel for plasma center operations

Our Goal at Scantibodies is to see that each Patient receives the Most Accurate Result, using the Most Accurate Guide,so that they may receive the Most Accurate Treatment. Because at Scantibodies it is all about the Patient ...At Scantibodies, we believe that being your contract manufacturer is more than just an account. It is about trust and accountability. It is about taking your prototype to production for market readiness or making your current process more cost effective by using lean manufacturing concepts. Those are just a few of the many attributes that have made us a leader in contract manufacturing.

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