Senior Quality Assurance Manager

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 11/14/17
Zumbrota, MN
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 11/14/17

Senior Quality Assurance Manager

Job Description

The Senior Quality Assurance Manager plans, coordinates, and directs facility Quality Assurance and Food Safety Programs in compliance with all DC policies, procedures, customer specifications, and regulatory requirements. The Senior Quality Assurance Manager will work collaboratively with the plant management team to improve overall plant performance. This position is a leadership role, and as such is expected to inspire employees to greater levels of professionalism, quality, productivity, and engagement with the DC team. Support and implementation of a Culture of Quality is paramount.

Duties and Responsibilities

  • Ensures daily plant Quality and Food Safety operations are in compliance with DC policies, procedures, customer requirements, and local, state, and federal regulations
  • Ensures escalation of non-conformance events to the proper operations and corporate QA personnel
  • Maintains robust and effective Food Safety and Quality Plans with supporting prerequisite programs
    • Collaborates with plant and corporate resources to ensure the plant is at a Regulatory state of readiness for FSMA
    • Monitors and makes recommendations for improvement
  • Customer Specification Management
    • Participates in the review of new and revised versions of specifications
    • Ensures that the plant has the capabilities to meet the customer specifications
    • Ensures ERP is aligned to report tests results and required information correctly on the certificate of analysis (COA’s)
    • Monitors compliance to customer specifications and communicates any issues/concerns
  • Manages “Hold and Release” programs for finished products and ingredients
  • Standardized Operating Procedures (SOP’s)
    • Ensures plant personnel have access to the most recent versions of the Corporate Standardized SOP’s and that all training records are current
    • Maintains a matrix chart by job description at the plant which indicates which SOP’s are applicable by job description
    • Prepares plant specific versions of SOP’s as directed by the Corporate SOP or as needed by the plant
    • Ensures all forms and work instructions are linked to the plant SOP’s and are reviewed, revised, and updated annually
  • Ultimate oversight of the plant laboratory operations (staff, training, and compliance to the DC Laboratory Quality Manual) for both the fluid and finished product laboratories
  • Auditing
    • Leads internal, customer, corporate, and regulatory audit visits
    • Engages cross-functional teams as required to ensure audit response reports are completed in the allotted time frame and sustainable corrective actions are identified, agreed to, and implemented within defined time lines
  • CAPA Systems (Corrective Action/Preventive Actions)
    • Manages all Quality and Food Safety CAPAs
    • Oversees team assignments to ensure proper root cause analysis and implementation of corrections and verification of effective/sustainable actions
  • Customer/Consumer Complaints
    • Manages the plant investigation for all complaints
    • Ensures timely response and a thorough review of all records and retains
    • Provides written reports to corporate QA Director
  • Maintains quality/food safety related certifications and licenses at the site
  • Implements and oversees Pathogen Environmental Monitoring Program
    • Ensures the programs are being followed, all corrective actions are completed, and all records are current
  • Conducts investigations into incidents and quality issues
    • Document findings, performs trend analysis, and communicates to management, employees, and customers as appropriate
  • Record Review
    • Ultimate oversight to ensure all record review is current for laboratory, sanitation, and production documents
    • Assesses product quality, ensures products meet DC and/or customer specifications, and approves products for release to customers
  • Conveys company, facility, and department goals to employees
  • Tracks and reports on plant quality Key Performance Indicators (KPIs) and ensures continuous improvement
  • Facilitates scheduling and/or delivery of quality/food safety training to meet corporate and regulatory requirements
    • Completes training as required, to maintain license and certifications required by the position
  • Sanitation Programs
    • Ensures all SSOP’s and associated forms are current and the programs are being followed
    • Participates in monthly meetings with the plant Sanitarian and sanitation service provider
    • Ensures all corrective actions from service reports are implemented
  • Pest Control Programs
    • Ensures the plant programs are current and being followed
    • Provides oversight and guidance to the plant Sanitarian in regards to supervision of the program
    • Reviews the monthly plant service reports, ensures corrections and corrective actions are being implemented
    • Ensures pest trends are monitored
  • Adheres to all DC Quality, Safety, and GMP policies and procedures and reports any nonconformity
  • Maintains current knowledge through seminars and industry publications to develop skills and improve job performance
    • Attends required training, including but not limited to Safety, GMP, HACCP, and Safe Quality Foods (SQF)
  • Ensure availability to respond to emergencies or other unexpected operational requirements (i.e., nights, weekends, or holidays)
    • Participates in on-call rotation
  • Participates in the annual plant budgeting process

Teamwork and Collaboration. May provide and/or receive input from across functional boundaries. Understands organizational mesh points and potential synergies. Integrates team efforts across the organization.  

Leadership. Acts with integrity. Treats others with dignity and respect. Models behavior that is consistent with DairiConcepts’ core values. Delivers on commitments and deadlines and holds others accountable for the same.   

Communication. Effectively communicates with all levels of the organization. Demonstrates excellent presentation, oral, and written communication skills. Executes outstanding customer communication and relationship building techniques.

RequiredSkills

  • Knowledge of Microsoft Office Suite and company computer systems, specifically Excel and ERP
  • Knowledge of principles and practices of supervision, training, and personnel management
  • Accuracy and thoroughness in completion of duties is crucial to success
    • Able to organize and prioritize resources to achieve goals, able to multi-task;, able to keep organized records, able to work with accuracy, and attention to detail
  • Able to take appropriate steps to find solutions to problems
  • Able to present options and ideas to current processes or procedures
  • Able to handle challenging or conflict situations with tact and professionalism
  • Able to promote a team environment
  • Able to multi-task and problem solve
  • Able to interpret and apply company policies
  • Able to adapt and manage to change effectively
  • Able to take initiative in performing job
  • Able to perform task and duties without constant supervision
  • Must be able to read, write, and speak English

RequiredExperience

  • Bachelor’s degreerequired in Food Science, Biological Sciences, or related field
  • 8years of experience in food processing environment, including 5 years of direct supervisory responsibilities
  • Prefer experience in dairy manufacturing
  • Certification and/or Licenses
    • HACCP certification
    • SQF Practitioner certified or obtain within first 90 days
    • PQCI certification
    • May be required to obtain and maintain other certifications and/or licenses in the future 

Potentially Reporting to this Position 

  • Manager-Quality Assurance
  • Quality Control Specialist / Laboratory Personnel
  • Sanitarian
  • Food Safety Specialist

Travel

  • 5%-15% (1-3 times per year)

Physical Demands and Work Environment

  • Office and manufacturing environment 
  • Frequently sits, stands, and walk
  • Frequently is exposed to loud noises > 80 decibels with ear protection
  • Occasionally grasps, handles, twists, and types; reaches; climbs; squats, kneels, and bends; and pulls/pushes
  • Occasionally exposed to chemicals and dust with protections
  • Occasionally is exposed to outdoor weather conditions; wet or humid conditions (non-weather); refrigerated temps (non-weather) < 40°; and elevated heat (non-weather) > 95° from dryers/retorts, etc.
  • Occasionally works in, around, and over lines/obstacles and in tight or narrow spaces 
  • Occasionally lifts 10-25 lbs
  • Ability to communicate, verbal and written
  • Ability to hear, read, and see

Other Responsibilities 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.