Drug Product Inspection Group Lead (Multiple Openings!)

Location
92121, San Diego
Posted
Nov 08, 2018
Required Education
High School or equivalent
Position Type
Full time

Let’s Make A Difference!

 

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

 

Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing andaseptic drug product fill in vials and syringes.

 

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

 

Together, Let’s Make A Difference.

 

Ajinomoto Bio-Pharma Services is currently seeking a Drug Product Inspection Group Lead to supervise and maintain the visual inspection processes of client products. The Group Lead implements and maintains production schedules and manpower requirements. The Group Lead directly provides guidance to employees to ensure operations follow SOP’s in a cGMP environment and provides general supervision over a work group, assigning tasks and checking work at regular intervals. The Drug Product Inspection Group Lead must also complete training and pass qualification testing for visual inspection of various product forms. Other key responsibilities may include interacting with outside vendors and departments, scheduling visual inspection activities, writing deviation reports, assisting in product defect/reject investigations, training operators, and writing/approving Maintenance Work Requests, Engineering and Facility Change Requests, and Purchase Requisitions.

 

Responsibilities:

  • Manage administrative duties of direct reports such as, timecards, attendance tracking, etc.
  • Projects as assigned by management.
  • Communicate shift project status to visual inspection leaders.
  • Participate in the interview and selection of potential visual inspection candidates.
  • Responsible for initiating and investigating product/process deviations. 
  • Generate purchase requests for material/equipment utilized in visual inspection.
  • Schedule and plan visual inspection project priority and labor requirements.
  • Manage daily assigned projects within Visual Inspection.
  • Perform sampling of finished product and enter into sample tracking system.
  • Creating and verifying Product/Sample identification labels.
  • Train and qualify new employees in visual inspection techniques. 
  • Review of finished product documentation for completeness and accuracy.
  • Perform characterization of product defects. 
  • Perform verification of inspection booth light intensity specifications.
  • Responsible for Visual Inspection, Line Clearance, and Good Documentation Practices (GDP).
  • Accurate receipt and counting of filled units from Fill Finish manufacturing.
  • Perform Bulk Packaging and Labeling of Vials or Syringes.
  • Follow all proper gowning procedures.
  • Perform verification room, equipment, and storage log books for completeness and accuracy. 
  • Generate work orders in electronic Maintenance system. 
  • Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Embodies Aji Bio-Pharma cultural values and aligns daily actions with department goals and company culture.

 

Requirements:

  • High School Diploma or equivalent. Bachelor’s degree in a Life Sciences discipline or equivalent strongly preferred.
  • Minimum of one (1) years of experience in a functional leadership role.
  • Minimum of four (4) years of relevant experience in a manufacturing or laboratory environment preferred and a minimum of three (3) years of experience in Visual Inspection of pharmaceutical products preferred.
  • Ability to supervise assigned staff in daily operations: Equipment/Room preparations, Inspection, Labeling and Packaging.
  • Monitors and communicates production metrics.
  • Ensure manufacturing documentation and areas are in an audit ready state.
  • Coordinates activities with other departments.
  • Ability to pass visual acuity exam according to SOP guidelines.
  • Ability to pass visual inspection qualification exams according to SOP guidelines.
  • Strong knowledge of automated and manual inspection techniques.
  • Review and verify document entries and data meets SOP and GDP requirements.
  • Good mathematics and computer skills.
  • Detail oriented with strong written and verbal communication skills.
  • Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
  • Ability to work independently, within prescribed guidelines, or as a team member.

 

Leadership Responsibilities:

  • Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
  • Engages employees by creating a climate in which they want to do their best.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  • Maintains employee work schedules.
  • Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

 

Successful candidate must pass a background check and drug screen as a condition of employment.

 

We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.