Quality Assurance Manager bei ProCaps Laboratories

POSITION SUMMARY

The QA Manager is responsible for the development, implementation and improvement of quality assurance programs associated with FDA and FSMA regulations for assuring consistent manufacturing quality and food safety by implementing current Good Manufacturing Practice (cGMP), providing documentation, managing QA team and supporting the QA department in maintaining a culture of Quality within the manufacturing areas. Implementing continuous improvement to meet department goals and make specific recommendations to develop KPIs, procedures and policies.

Competencies:

• Intelligent, Strategic Thinker and Results-driven Thinker

• Respected, Inspirational, and Hands-on Leader
• Excellent Communicator with strong writing and interpersonal skills
• Analytical, Process-oriented, and Solution-focused Decision Maker
• Creative and Innovative Problem Solver

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

• Develop, review, and improve company quality management systems, HACCP, standard operating procedures (SOPs), training materials, and documentation to ensure compliance of regulations for the dietary supplement and food products.
• Support and lead in liaison with the FDA and other federal, state, and local agencies that visit, inspect, or audit ProCaps Laboratories.
• Perform internal food safety audits, review manufacturing processes and recommend improvement and submit reports to senior management.
• Hire new personnel, coordinate staff attendance schedules, including vacation approval.
• Accomplish results through coaching, mentoring, and counseling employees, implementing CAPA and progressive discipline as necessary; monitor and appraise individual jobs.
• Implement company policies and procedures, generate quality reports, conduct weekly department meetings, attend and participate in operations meetings.
• Prepare for and conduct weekly department meetings, as well as other quality related meetings such as: Food Safety committee, NCR, CAPA, and internal audit summary meetings.
• Responsible for conducting, monitoring and administration of Mock Recall procedure.
• Ensure required tracking reports are generated accurately and timely for the following but not limited to:

• o Customer Complaints
• o Nonconformance and Deviations
• o Quarantined Materials
• o Change Control Documentation
• o ProCaps Laboratories (PCLE) Quality Assurance Management.

• Perform other duties and responsibilities as assigned.

WORK ENVIRONMENT

• Duties are performed primarily in a smoke-free office and production environment

Requirements

MINIMUM JOB QUALIFICATIONS

• Bachelor of Science in a natural or physical science (Chemistry, Biochemistry, Biology, or Microbiology) preferred.
• Minimum of 10 years’ experience in the area of Quality Assurance in a FDA environment as Pharmaceutical, Dietary Supplement, Cosmetics, or Food manufacturing to include a minimum of five years in a Leadership capacity.
• Strong working knowledge of cGMP and GLP.
• Proficient in Microsoft Office.
• Familiarity with FDA regulations.
• Possess excellent verbal and written communication skills.
• Strong leadership and team-working capacities. Detail and quality oriented.
• Contributes to a working environment that allows all employees equal opportunities for skills development, growth, and advancement in the department.
• Conducts business in compliance with the ProCaps Laboratories Code of Business Conduct.

Benefits

ProCaps provides :

• A competitive salary!
• Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!
• Paid Time Off, Eight (8) Company Holidays
• 401(k) with Company Match – up to 4.5%
• 100% Company Life Coverage
• 100% Short Term Disability Coverage
• Gym Membership Reimbursement
• Vitamin Allowance + Discounts
• Company-Funded Health Savings Account ($1,600/year)
• Cash Reward Employee Referral Program
• Pet Insurance
• Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!