Job Summary

Prolacta Bioscience is seeking a Senior QC Method Development and Validation Analyst, fully competent to serve as a senior level Subject Matter Expert (SME), technical resource and contributor in one or more specialized functions. The Senior QC Method Development and Validation Analyst is required to lead and support the development, validation, and implementation of methods used for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. Additionally, the Senior QC Method Development and Validation Analyst is required to lead and support, OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigations. This role is required to provide expertise across multiple disciplines within the laboratory and to provide method development, validation, and implementation support.

Primary Duties and Responsibilities

• Experience with anaerobic and aerobic microbiology techniques and phenotypic characterization of diverse microbes
• Deep expertise in microbial and molecular biology testing methods, including cell culture and identification by qPCR
• In-depth understanding and adherence to the Quality System requirements established by Prolacta Bioscience
• Knowledgeable in all conventional aspects of field
• Demonstrates full understanding of routine laboratory procedures
• Demonstrates expert knowledge of project/process flow within discipline
• Applies extensive technical expertise and has knowledge of other related business disciplines/processes
• Independently evaluates, selects and applies standard techniques and procedures
• Supports the development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
• Preparation of experimental design, analytical method development, and analytical method validation protocols and reports
• Explores new methodology for improvements
• Provides subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing (OOSs, NCs, LIRs, ORs, CAs and/or CAPAs) and other investigations as necessary
• Provide subject matter expertise for the evaluation and conclusion of laboratory investigations
• Utilizes significant knowledge of raw materials and finished goods testing in preparing conclusions and recommendations
• Frequent inter-organizational and outside customer contacts; represents the organization in providing solutions to difficult technical issues associated with specific projects
• Support/lead various QC projects with the design, testing, and implementation phases
• Operates, maintains, and troubleshoots advanced analysis equipment

• May make minor adaptations and modifications
• Support the development and execution of validation studies and research projects
• Works on complex projects requiring evaluation of materials testing
• Participating in self-inspections and regulatory inspections
• Provide data analysis and trending
• Provides technical solutions to a wide range of difficult problems

• On-going continuous improvement projects
• Ability to enter and manage data within a LIMS system
• Write and/or revise Prolacta Standard Operating Procedures (SOPs)
• Write and/or review test specifications

• Provides leadership, guidance, and training to junior colleagues on a regular basis

Job Requirements and Qualifications

·  Bachelor’s degree in Microbiology, Molecular biology and Biotechnology, Biochemistry or related discipline; MS/PhD in technical field highly desired

·  Minimum of 6 years with BS/3 yrs MS/PhD with hands-on experience in quality control, manufacturing, operations, or pilot lab/scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry/microbiology high desired

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

Other Knowledge, Skills and Abilities

·   Business Acumen – Demonstrates advanced knowledge of Prolacta products, technical operations, strategy, industry trends, and Prolacta SOPs

·    Collaboration

- Develops cross-functional partnerships and initiates new and productive           internal/external alliance

- Solicits feedback regarding improving processes

·     Communication

– Regularly interacts with team members, management, contacts among functional areas, and other departments within the company

·    Computer Skills

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

• Critical Thinking

– Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems

·      Customer Focus

 - Ensures products meet client requirements

- Assesses customer needs and develops options to meet those needs

- Presents options and recommendations to management/customer

- Performs highly detailed work on multiple, concurrent tasks, while working under strict deadlines

·       Good Judgment – Work performed without appreciable direction

·         Guidance

- Provides constructive feedback to help others develop

- Builds consensus, encourages two-way feedback, and acknowledges contributions of others

- Encourages work group members to pursue excellence through diverse perspectives

·         Problem Solving

- References and researches established practices, standards and/or policies to provide solutions to a variety of difficult problems

- Effectively challenges current processes and recommends improved approaches; solutions are thorough, practicable, and consistent with organization objectives

·         Teamwork

- Ability to work independently and as part of a team

-  Facilitates cooperative behavior among departments

• Written/Oral Skills – Regularly required to demonstrate strong written communication and oral skills

 

Work Environment (Location, Travel, Shift, On-Call, etc.)

• This position requires working in a laboratory/office setting for an 8 hour shift
• Required to support the QC Lab at both the City of Industry and Duarte locations
•  Up to 10% car travel between locations may be required

Physical Requirements

a.       Activities. How much on-the-job time is spent in the following physical activities?

 

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

 

Direct Reports

·         None