Quality Engineer

Location: San Diego Cleanrooms OnDemand

Job Description

Azzur Cleanrooms on Demand (COD) is looking for a quality manager to perform and verify GMP activities per approved procedures to support cleanroom and raw material program operations for internal and client manufacturing operations.


Essential Functio
ns

Perform and verify GMP raw material management per approved procedures:

  • Provide quality oversight of materials management, shipping and receiving, aseptic raw material sampling per an approved specification, inventory control assignments and various client required assignments. These duties ensure client and internal COD operations are performed in compliance with relevant site and client procedures and pertinent regulatory requirements. Typical duties include oversight and review of:
    • Shipments and documented according to site and client procedures.
    • Client material shipments in compliance with temperature control and chain of custody requirements.
    • Raw material sampling forms and associated inventory control. 
    • Sign as Quality for the release of controlled raw materials intended for GMP use. 
    • Review of internal GMP operations to ensure compliance with relevant procedures and regulations.

 

Support Internal and Client Quality Management Systems. Examples of these duties include:

  • Support quality systems that document the cause and effect of events that deviate from normal operations. Implement corrective and preventive actions (CAPA). Examples are material handling excursions, controlled area environmental excursions and facility operation service interruptions.

 

Provide onsite client support during cleanroom operations to ensure client business needs are executed as planned. This support can include off-hour support (weekday evenings and weekends).

  • Review and approve client raw material transactions needed to support manufacturing operations.
  • Provide training to clients to ensure compliance with the COD Quality Management System.
  • Write and execute validation documents and standard operating procedures to support the commissioning and qualification of internal and client equipment or process operations as agreed to in client Statements of Work or per internal expansion plans.

Maintain the facility in a state of audit readiness. Ensure operations are being performed correctly per approved procedures. Identify and implement process improvements. 

  • Perform housekeeping and restocking duties. Review logbooks on a routine basis.  
  • Ensure procedures are being followed as written for all COD personnel and clients. 
  • Identify process improvements that enhance compliance and/or operational efficiency, such as reduction in non-value activities, elimination of wastes, and improvements in operational flow.

 

Behavioral Requirements

  • Handling multiple responsibilities and job tasks (multi-tasking) as needed.
  • Demonstrating attention to detail. 
  • Flexibility with work requirements, work environment and fast-paced/changing job needs.

 

Promoting teamwork by:

  • Understanding team dynamics and team formation. 
  • Collaborating with co-workers.
  • Attending staff meetings as required.
  • Meeting individual and facility goals as established.
  • Establishing rapport and maintaining positive communication with internal personnel and clients, demonstrating respect and support, cooperating and flexibility with change. 
  • Adhering to company and department policies.


Basic Qualifications & Position Requirements:

Required Education:

  • Bachelor’s degree or higher in a scientific discipline

 

Preferred Education:

  • Bachelor’s Degree or higher in a scientific discipline 

 

Required Work Experience:  

  • 1 yr. experience in a Quality position

 

Preferred experience:

  • 2 yrs. experience in Quality position
  • GMP experience is highly preferred
  • Raw Material handling and aseptic technique experience preferred
  • Cleanroom experience is highly preferred

 

Required Knowledge:

  • Microsoft Office

 

Skills (Including Typical Mental Demands):

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

  • Computer skills, basic mathematical skills, use of spreadsheets, clear penmanship. 

 

Additional Qualifications: 

  • Customer service/client relations
  • Communication proficiency
  • Attention to detail
  • Can work productively independently with minor supervision
  • Self-motivated, flexible, dependable and available
  • Excellent organizational and time management skills

 
Must be able to consistently lift 20 lbs. and be mobile for the majority of the workday.

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

Azzur is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Azzur also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Azzur is an E-Verify employer.

Azzur is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

 



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