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Quality Analyst - Pharma

Tracy, CA USA
Requisition ID:  15684
No of Openings:  1
Posted Date:  Aug 3, 2022
Job Function:  Quality & Food Safety

Summary Description:

This position leads plant Quality initiatives for Pharma Lactose and operates as the local subject matter expert in applicable safety and quality policies, programs, and systems. 

This position is responsible for facilitating and ensuring compliance with the Quality Systems for Pharma Lactose as it relates to Regulatory, IPEC and Customer Audits. This position serves as the liaison between the facility and the customer auditing group or NSF. This position is also responsible for consulting and assisting Corporate Quality in related audit preparation and execution.

Job Duties (Accountability Categories and Essential Functions/Key Responsibilities):  NOTE:  The job may include other “non-essential” responsibilities and duties that are not listed on this form.


Accountability Category

Essential Functions/Key Responsibilities

% of Time

  1. 1

Quality Programs

  • Leads plant food safety and quality programs/initiatives for Pharma (excipient) Lactose and operates as the local subject matter expert in applicable Quality Execution and Quality Assurance policies, programs, and systems.
  • Drives proactive and ongoing preparation for and follow-up on all regulatory, Kosher, Halal, customer, third party (I.e. NSF), and corporate compliance audits for Pharma lactose. 
  • Manages compliance of applicable food safety programs and quality systems by leading full cycle food safety and quality systems compliance audits for Pharma Lactose and partnering with department managers and supervisors to implement effective corrective and preventive actions to prevent recurrence of previously identified compliance opportunities.
  • Assures robust and detailed document control procedures are established and executed.
  • Completes detailed, periodic, compliance reporting and shares results with management to promote ongoing awareness of the plant’s state of compliance and needed support to drive plant food safety and quality systems continuous improvement initiatives.
  • Manages the plant Corrective and Preventive Actions (CAPA) Program for Pharma Lactose to ensure food safety and quality systems process improvements are documented to include root cause(s), corrective action(s), preventive action(s), and problem recurrence monitoring to know and be sure root cause(s) were effectively addressed.
  • Coordinates with plant personnel to follow up on customer issues (complaints, audit responses, customer queries, etc.).


  1. 2

Technical Writing

  • Assists  with the development, editing, formatting, and validation of the Pharma Lactose SOPs,  Quality Manual and corresponding documents and forms to become successfully certified by NSF and approved by commercial Pharma Lactose partners.
  • Assists with the optimization of the established Pharma program as needed based on self-audits, as well as by customers and NSF.


  1. 4

Customer Audits

  • Collaborate with Leprino Foods’ Pharma Lactose partners, corporate stakeholders, and customers to schedule necessary customer audits each year.
  • Review customer audit requirements and advise
  • Support cross references on customer requirements vs policy, procedure and or documentation, educating the plant on requirements and other preparation assistance.  
  • Ensure supplier questionnaire completion prior to audit.
  • Ensure Customer Audit corrective actions are complete and submitted on time. Acts as plant liaison with Corporate QA, Pharma Lactose partner and customers to ensure audit reports are successfully closed out.


  1. 5

NSF Liaison, Scheduling, and Support

  • Stay updated and educated with IPEC Standard and requirements
  • Assist plant team in training related to IPEC standards.
  • Provide IPEC and Quality Management expertise on processes and procedures to meet IPEC standard.
  • Assist the plant with updates to their Pharma documentation and work with the plant and Corp QA regarding procedures and processes to meet IPEC standards
  • Maintain NSF on-line portal for IPEC CARS.
  • Schedule NSF and internal audits.
  • Facilitate the corrective action process for NSF audits, including review of corrective actions written by the plant, meeting timeline of CARS for the audits, uploading CARS to the NFS system and keeping plant aware of the approval status for each corrective action.
  • Work with the certifying body (NSF), on any problems that arise or on continuous improvement initiatives.



Production Support

  • Ensures compliance with policies, procedures, and systems in the areas of Pharma Lactose Quality and Food Safety, customer interface, analytical performance testing methodologies, and purchase quality control. 
  • Troubleshoots plant quality and food safety program-related issues.


  1. 7


  • Promotes a positive food safety and quality culture on the floor via routine floor surveys focused on assessing, reporting, and driving improvements with all plant team members. 
  • Utilize these surveys to lead improvement initiatives with plant team members to help energize engagement with food safety and quality opportunities.
  • Leads cross-functional continuous improvement initiatives via development, implementation, and focus on trends to prevent quality and food safety programs non-compliance.
  • Develops and implements food safety and quality systems education for Pharma Lactose and maintains current requisite certifications (I.e. HACCP, PCQI, Internal Auditing, etc.).


Location Specific Detail:

Include any unique location specific details for this position that are not covered in the above job duties.


Minimum Qualifications & Experience:

  • Bachelor’s Degree in food technology, food science, dairy science, microbiology, or chemistry, or equivalent experience working in a regulated food manufacturing environment
  • 3+ years of experience in quality systems, compliance, or related experience 
  • Knowledge of and passion for leading plant food safety programs and quality systems

Preferred Qualifications & Experience:

  • Pharma or Pharma excipient manufacturing experience
  • Experience with NSF and customer audits
  • Experience in defining SOPs and technical

Knowledge, Skills & Abilities/Competencies: 

  • Ability to balance multiple priorities
  • High sense of urgency for problem solving and continuous improvement
  • Influential leadership presence and a teamwork-oriented
  • Strong level of assertiveness needs to be balanced with exceptional interpersonal skills to achieve results in a positive and collaborative manner
  • Willing to take input from other departments and be capable of prioritizing workload to complete tasks efficiently
  • Excellent verbal and written communication skills to communicate with others and create and maintain the Pharma Lactose Quality Program.
  • Knowledge of Food Safety and Quality Management Systems
  • Knowledge of NSF and GFSI Food Safety and Quality Standards
  • Intimate knowledge of GMP, HACCP, hazard analysis, quality programs and sanitation standards for pharma excipient manufacturing
  • Ability to work independently under self-direction approximately 40% of the time; and under external direction approximately 60% of the time
  • Ability to solve problems in straightforward situations; analyzes possible solutions using technical experience and judgment
  • Proficient computer skills including MS Office, Excel, PowerPoint

Leprino Foods Company utilizes the services of Psychemedics to perform our Hair Follicle Drug Testing.  Additional information about this process can be obtained at
Leprino Foods requires all individuals to wear the appropriate Personal Protection Equipment (PPE) as required by the role and location.
Leprino Foods Company supports a drug-free workplace and is an EEO/Affirmative Action Employer – M/F/Disability/Veteran

Nearest Major Market: Stockton