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Director of Quality Assurance

ProCaps Laboratories
North Egremont, MA Full Time
POSTED ON 12/5/2021 CLOSED ON 2/3/2022

What are the responsibilities and job description for the Director of Quality Assurance position at ProCaps Laboratories?

Position* : Director of Quality Assurance*

Job Location: ONSITE in HENDERSON, NEVADA

JOB OVERVIEW
ProCaps Laboratories is a large but still rapidly growing manufacturer of several hundred dietary supplement SKUs, along with a rapidly expanding line of functional foods (nutritional bars, plus others), all of which are 100% additive free and manufactured using 100% solar power in our zero-carbon footprint facility. We are looking for a DIRECTOR OF QUALITY ASSURANCE responsible for directing excellence in quality during the production cycle by providing technical leadership within the quality discipline, driving adherence to established standard operating procedures. Additional duties will be to work directly with internal departments, suppliers, and various agencies to effectively resolve problems and must be able to drive continuous improvement in the facility.

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

  • Bachelor’s degree in a scientific discipline
  • Minimum of 10 years’ experience in the area of Quality in an FDA regulated manufacturing environment; to include a minimum of 5 years in a leadership capacity
  • Minimum of 3 years of managing regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business
  • Strong leadership and team-working capacities
  • Possess excellent verbal and written communication skills
  • Efficient problem solving and data-driven decision making in a fast-paced environment

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

  • Direct departmental operations for Quality Assurance and Document Control
  • Ensures required cGMP training for both new and existing staff is implemented as it relates to Title 21 Code of Federal Regulations, Part 110, 111 & 117 requirements
  • Leads and participates in audit preparation and inspections by certifying agencies and regulatory bodies, i.e. NSF and FDA
  • Ensures all departments development appropriate quality-related processes, standard operating procedures (SOPs), training materials, and documentation to ensure compliance with all federal regulations for the dietary supplement industry
  • Leads and/or supports investigations through effective Corrective Actions and Preventive Actions (CAPA) processes
  • Manage internal auditing of all departments and submit reports to senior management
  • Implement department goals and make specific recommendations for goals, objectives, and policies
  • Develops staff through feedback, coaching, counseling and support
  • Prepare for and conduct weekly department meetings, as well as semi-monthly Production/Quality meetings
  • Ensure required tracking reports are generated accurately and timely:
  • Customer Complaints
  • Nonconformance and Deviations
  • Quarantined Materials
  • Change Control Documentation
  • Perform other duties and responsibilities, as assigned

*
WORK ENVIRONMENT

*

  • Duties are performed primarily in a smoke-free office and production environment
  • ProCaps Laboratories will follow the new Federal guidelines requiring all employees to be vaccinated and has adopted a policy regarding mask-wearing that follows CDC guidelines. All employees and visitors are required to wear a mask while in public and shared spaces in the ProCaps Laboratories facility. Masks may be removed in your private work area when you are alone.

BENEFITS AND COMPENSATION
ProCaps Laboratories provides competitive compensation, commensurate with your experience and the position’s responsibilities, along with a comprehensive benefits package, which includes:

  • Excellent Medical Insurance
  • Excellent Dental Insurance
  • Excellent Vision Insurance
  • Paid Time Off, Holiday Pay
  • 401K matching program after 60 days of employment
  • 100% Company Life and Short-Term Disability Coverage
  • Health & Wellness Program
  • Reimbursement for Gym Membership Fee
  • Vitamin Allowance/Discounts up to 90%
  • Company Funded - Health Savings Account

PROCAPS LABORATORIES
Founded in 1979 by Andrew Lessman, ProCaps Laboratories has long been dedicated to enhancing health and well-being by providing the highest-quality dietary supplements.
For over 40 years, ProCaps Laboratories has led the industry in research, development and innovation, continuously advancing product formulations based on cutting-edge nutritional science and progressing technology. This unique company remains one of the few that actually develops and manufactures each of its products in a state-of-the-art, 100% solar powered, zero carbon footprint, eco-friendly, award-winning facility.
Today, Andrew Lessman remains the sole owner of the company and carries his vision through the core values of the corporation: to enhance health naturally by sustaining and ethically creating safe, pure, and effective nutritional supplements in an environmentally responsible way.
For more information about the company, visit:

  • The Andrew Lessman brand store on Amazon.com
  • Andrew Lessman on HSN.com (Home Shopping Network)
  • ProCapsLabs.com (currently going through a major overhaul)

ProCaps Laboratories is an equal opportunity employer and values diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status or disability status.
Depending on the volume of interests and submissions, we will only be contacting applicants who meet all of the minimum requirements listed in the job description. Only those applicants who align most closely with our minimum and preferred qualifications will be contacted for an interview. ProCaps Laboratories will retain your application materials for one year and may contact you regarding future opportunities.

Job Type: Full-time

Schedule:

  • Monday to Friday

Application Question(s):

  • Are you willing to relocate to Nevada?

Education:

  • Bachelor's (Preferred)

Experience:

  • Director of Quality in an FDA manufacturing environment: 10 years (Required)
  • cGMP manufacturing implementation: 10 years (Preferred)
  • CAPA processes and investigations: 10 years (Preferred)

Work Location: Multiple Locations

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