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Knox Medical - Lake Worth

Quality Assurance Associate

️ Compliance

The Quality Assurance Associate (QAA) will be accountable for the development, implementation and ongoing monitoring of the quality assurance and control systems in strict compliance with the Cannabis Act and Cannabis Regulations (CACR). The Quality Assurance Associate is accountable for assisting with the sites Quality Assurance operations.

KEY RESPONSIBILITIES

  • Quality Assurance regulatory compliance, Quality Control, internal and Health regulatory compliance and audits, and GAP identification.
  • Maintaining performance standards, procedures, and audit controls to meet Health requirements under the CACR and standard operating procedure and work instructions development and approval.
  • Maintenance of GPPs as they pertain to premises, equipment and sanitation, complying with quality assurance policies.
  • Oversight of an effective sanitation program to ensure production, packaging, labeling and storage activities involving cannabis are conducted under sanitary conditions;
  • Assist with recalls, complaint management, approval of product quality prior to approval for sale; product return management; sample retention; and reporting adverse reactions.
  • Identify and implement process improvements to increase the efficiency, effectiveness, and quality, oversee new equipment implementation or modification and validation.
  • Work with production team performing in product manufacturing processes validation for regulatory submissions, and preparation for regulatory inspections and commercial production.
  • Adherence to the Standard Operating Procedures (SOPs) for the Good Production Practices (GPP) of the Licensed operations, and the drafting of all SOPs and their work instructions, and training staff in these for correct implementation in operations and regulatory compliance.
  • Staff training to ensure regulatory compliance with all aspects of the CACR to meet Health standards and high standards of quality control.
  • Assist with other production tasks as needed.

    • QUALIFICATIONS/EXPERIENCE

  • Experience in QA/QC, supporting Pharmaceutical, Manufacturing or other regulated industry.
  • Some GMP knowledge with a focus in operational excellence in GMPs, recalls, electronic and hard copy records in an operational environment.
  • Some experience in identifying GMP gaps with experience in writing SOPS, work instructions, identifying GAPs, and with regulatory compliance and internal and external audits experience.
  • Exposure to and working knowledge of manual and computer-generated batch records and record keeping complying with the Canadian Food Safety and Environmental Program, FDA, pharmacopoeia and other related regulations.
  • Experience in an ISO: 9001, ISO: 13485 or ISO: 17025 environments is an asset.

    • SKILLS/INTERESTS

    Strong relationship and interpersonal skills especially with diverse groups of people

    Collaborative and inclusive leader who can inspire and empower others

    Entrepreneurial attitude with an interest in learning, understanding, growing, and improving the business

    A champion of change with courage of convictions

    Detail-oriented, well-organized, focused, and driven

    Excellent communication skills, both written and verbal.

    Strong integrity and the ability to influence others.

    WORK ENVIRONMENT

    This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

    PHYSICAL DEMANDS

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to sit, walk and stand for long periods of time; use hands to finger, handle or feel; and reach with hands and arms.

    POSITION TYPE / EXPECTED HOURS OF WORK

    This position regularly requires long hours and frequent weekend work.

    TRAVEL

    Travel is primarily local during the business day, although some out-of-the-area travel may be expected.

    REQUIRED EDUCATON and EXPERIENCE

    Bachelor’s Degree (or equivalent) in Biotechnology, Engineering, Life Sciences, or equivalent Quality Assurance and regulatory certification courses considered an asset.

    OTHER DUTIES

    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.

    AAP/EEO Statement

    Fluent is an equal opportunity employer and we welcome applications from all backgrounds regardless of race, color, religion, sex, ancestry, age, marital status, sexual orientation, gender identity, disability or any other classification protected by law.

    COMPANY BENEFITS

    Fluent provides comprehensive benefits offerings to all full-time employees. Our benefits include medical, dental and vision insurance, and paid time-off program.

    All applicants must be legally authorized to work in United States and will be required to submit proof of such eligibility.

    Experience: compliance: 2 years (Preferred) Quality Assurance: 2 years (Preferred)

    Education: Bachelor's (Required)

    Location: Winter Garden, FL (Preferred)

    Benefits offered: Health insurance Dental insurance

    01 Jul 2019

    Salary:
    DOE
    Company:
    Knox Medical - Lake Worth
    Type:
    Full-Time
    Licence:
    No required
    City:
    Winter Garden Florida, United States
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