Drug Product Inspection Group Lead - 2nd Shift
San Diego, CA 
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Posted 1 month ago
Job Description

Together, 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, 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 and aseptic drug product fill in vials and syringes.

 

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

 

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

 

We are currently seeking a Group Lead to join the 2nd shift of the Drug Product Inspection Department. In this role you will implement and maintain production schedules and manpower requirements while providing guidance to employees to ensure operations follow SOP’s in a cGMP environment. As a Drug Product Inspection Group Lead you will be responsible for supervision over a work group, assigning tasks and checking work at regular intervals. 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.

 

The Drug Product Inspection Group Lead will be required to complete training and pass qualification testing for visual inspection of various product forms.

2nd shift hours are typically 3:00 – 11:30 pm, Monday - Friday, however flexibility on hours worked is required.  

 

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’s 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 four (4) years of relevant experience in a manufacturing or laboratory environment. Minimum of three (3) years of experience in Visual Inspection of pharmaceutical products. Minimum of one (1) years of experience in a functional leadership role.
  • 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.

 

We provide a Total Rewards package designed to make life better – both at work and at home.

  • Annual Bonus Opportunities for All Employees
  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
  • Annual Company Shutdown in December
  • Comprehensive Medical, Dental + Vision
  • 401K Company Match + Immediate Vesting
  • Backup Daycare and Eldercare
  • Monthly Employee Appreciation Events and Food Truck Fridays
  • Employee Discount Programs
  • Tuition Reimbursement
  • Casual Dress Code
  • Wellness Programs
  • Community Outreach Opportunities

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.

New hires will 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

 

 


"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."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
4 years
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