Job Summary

Prolacta Bioscience Laboratory Supervisors are required to oversee 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. In addition, this role will require to 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 for the laboratory specialists and technicians
• Establish and maintain the scheduling for laboratory testing for the staff within the supervisors shift
• Coordinate testing activities with the other laboratory supervisor(s)
• 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
• Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
• Provide and coordinate support for the development and execution of validation studies
• Participate in out-of-specification and other investigations as necessary

 

Job Requirements and Qualifications

 

·         Good documentation skills required

·         Experience working in a laboratory that performs 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

 

·         BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering or related field

·         Minimum of 5 years with BS in Pharmaceutical, Biological or Biotech industry; hands-on experience in 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; 1-2 years in manager role

 

Other Knowledge, Skills and Abilities

 

·         Some experience in managing budget

·         Ability to work without supervision

·         Effectively interview and select candidates

·         Handle conflict management and bring resolution

·         Effective relationship building skills

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

·         Performance coaching and directing of others

·         Positive attitude and motivation

·         Ability to operate in a complex matrix environment

·         Strong PC skills, MS Outlook, Word, etc.

·         Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

·         Strong Critical thinking and decision making skills

·         Strong business ethics

·         Scorecard management

·         Lean and Six Sigma preferred

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

·         Ability to manage data and testing within a LIMS system

 

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

 

·         This position is required to support testing at both the City of Industry and Duarte Prolacta locations. Travel (car) between locations may be required. Up to 10% travel may be required.

·         4/10 work schedule

 

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