Job Summary

 

The Quality Control Supervisor is responsible for overseeing testing on incoming raw materials, in-process samples, final product, and facility/utility sampling. This individual will be responsible for the direct supervision of laboratory specialists and technicians and will guide and train staff on the performance of chemistry and microbiological assays in a GMP laboratory.

 

Primary Duties and Responsibilities

 

  • Understand and follow the Quality System requirements established by Prolacta Bioscience
  • Provide supervisory oversight of laboratory specialists and technicians including mentoring, talent development, team building and conflict resolution of the laboratory team
  • Establish and manage staff scheduling for laboratory testing
  • Perform and coordinate testing activities as needed to meet production needs
  • Oversee laboratory testing for laboratory samples (raw materials, incoming raw milk, in-process, final CofA, environmental monitoring, water, and stability) in an accurate, efficient, and timely manner
  • Ensure compliance with the State of California and Federal licensing/accrediting standards (CLIA)
  • Understand and follow Quality System Documents and SOPs relevant to responsibilities and testing
  • Provide and coordinate support for the development and execution of validation studies
  • Participate in out-of-specification and other investigations as necessary
  • Represent the department and interface with auditors for internal and external audits

·         Actively participate in the interviewing and training process for new team members

·         Support/Lead various QC projects in the design, testing and implementation phases

 

 

Job Requirements and Qualifications

 

·         Excellent documentation skills

·         Experience working in a laboratory that performs high through-put, high complexity testing within a regulated environment

·         General knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred

·         Experience with the planning, specifications, validation, and administration of LIMS systems preferred

·         Must be capable of working in a FDA regulated environment

 

Qualifications

 

·         CA CLS license with minimum of 1-2 years in a CLIA certified laboratory

·         BS in Medical Technology, Clinical Laboratory, Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering or related field

·         Minimum of 1 year training and experience in high-complexity testing or 5 years of hands-on experience in Pharmaceutical, Biological or Biotech manufacturing operations or pilot lab/scale-up operations

·         Experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry highly desired

·         Minimum 1-2 years of experience in supervising a laboratory team is required

 

Other Knowledge, Skills and Abilities

 

·         Budget management experience

·         Ability to work with minimal supervision

·         Effective relationship building skills

·         Ability to produce and present clear, concise and professionally written communications and presentations

·         Positive attitude and motivation

·         Ability to operate in a complex matrix environment

·         Strong PC skills

·         Demonstrated ability to successfully work under pressure, meet deadlines, and successfully work on multiple projects simultaneously

·         Strong Critical thinking and decision-making skills

·         Strong business ethics

·         Scorecard metrics management

·         Lean Six Sigma experience preferred

·         Ability to manage data and testing within a LIMS system

 

Work Environment (Location, travel, shift, on-call, etc.)

 

This position will support testing at both our City of Industry and Duarte locations. Travel (car) between locations may be required.  

Flexible work schedule to meet the needs of supervising a two-team rotation.

 

Physical Requirements

 

This position requires working in an office environment and may require occasional work within the laboratory. Testing that is performed within the laboratory will require the ability to handle and dispose of hazardous materials.

 

a.    Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Stand

 

 

 

X

Walk

 

 

 

X

Sit

 

 

 

X

Talk or hear

 

 

 

X

Use hands to finger, handle or feel

 

 

 

X

Climb or balance

X

 

 

 

Stoop, Kneel, crouch or crawl

X

 

 

 

Reach with hands and arms

X

 

 

 

Taste or smell

X

 

 

 

 

b.    Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Up to 10 pounds

 

X

 

 

Up to 25 pounds

 

X

 

 

Up to 50 pounds

X

 

 

 

Up to 100 pounds

X

 

 

 

More than 100 pounds

X

 

 

 

Direct Reports

 

QC Lead Specialists

QC Specialists

QC Technicians

 

 


This position has been filled.