Job Summary

 

Prolacta Bioscience Senior Quality Control Analyst is required to support testing on incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. In additional to direct testing, the Senior Quality Control Analyst is required to support OOS (Out Of Specification), NC (Non-Conformances), LIR (Laboratory Investigation Report), contract laboratory support, and provide general quality systems support for the laboratory (i.e. SOP, CAPA etc.). This role is required to lead and provide expertise across multiple disciplines within the laboratory and to provide method development/validation support. This role is an entry level supervisory developmental role that will direct day-to-day staff activities including assignment of resources.

 

Primary Duties and Responsibilities

 

  • Subject Matter Expert of the following laboratory activities: 
    • Testing of all incoming raw materials, raw milk, in-process, final container and stability samples in an accurate, efficient and timely manner
    • Perform environmental monitoring of manufacturing areas and utilities
  • Support the development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
  • Develop the necessary testing and criteria for the execution of validation studies and projects

 

  • Provide technical solutions to a wide range of difficult problems. Provide solutions that are imaginative, thorough, practicable, and consistent with organization objectives
  • Frequent inter-organizational and outside customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with specific projects
  • Writing/reviewing of SOPs
  • Provide data analysis and trending
  • Provide subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing (OOS, NCs, LIRs, SOPs, CAPAs) and other investigations as necessary. Good documentation and investigation skills required
  • Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
  • Completing any other designated tasks, as necessary
  • Supporting on all analytical activities
  • Participating in self-inspections and regulatory inspections
  • Understand and follow the Quality System requirements established by Prolacta Bioscience
  • Drive department goals/objectives
  • Manage and approve employee time sheets, overtime and paid time off
  • On-going continuous improvement projects

·         Assist in  writing and deliver year-end reviews

  • Training and cross-training of junior employees
  • Be familiar with area SOPs and insure standardized work is followed
  • Respond to junior employee’s issues/requests
  • Lead projects
  • Direct day-to-day staff activities including assignment of resources - May supervise others as assigned
  • Able to perform supervisor duties and responsibilities when needed
  • Facilitate and/or support Quality Control laboratory 5S; tour/audit ready at all times
  • Assist management with team morale, metric reports, employee development, training, etc.

 

 

 

 

 

 

Job Requirements and Qualifications

 

·         In-depth understanding and wide application of technical principle, theories and concepts in the field

·         Knowledge of Microbiology and Biochemical techniques and other related disciplines.

·         Consistent use of best practices and knowledge of internal or external business issues to improve products or services

·         Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1)

·         Excellent interpersonal, communication, presentation and organizational skills

·         Experience working in a laboratory that performs testing within a regulated environment

·         Working Knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred

·         Must be capable of working in a FDA regulated environment

 

 

Qualifications

 

·         BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Chemistry or other applicable related fields; MS/PhD in technical field highly desired

·         Minimum of 4 years with BS (3 years with advanced degree) 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/microbiology highly desired

 

 

Other Knowledge, Skills and Abilities

 

·         Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)

·         Attention to detail

·         Strong analytical and problem solving ability

·         Self-starter and self-motivated, with the ability to work proactively using own initiative

·         Ability to work independently and as part of a team

·         Adaptability and a positive attitude

·         Ability to multi-task

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

·         Hands-on approach, with a ‘can-do’ attitude

·         Ability to enter and manage data 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.

 

 

Physical Requirements

 

This position requires working in a laboratory setting for an 8 hour shift. Laboratory testing includes the handling and disposal of hazardous materials. Office work will also be required for the analysis and reporting of data.

 

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

 

None

This position has been filled.