9 days old

OTC Pharmaceutical General Plant Manager

Calmo Manufacturing Inc
Huntington Beach, California 92647
  • Job Code
    ISPE - Plant Mgr
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Calmo Manufacturing, Inc. exclusively manufactures Calmoseptine Ointment which is an over-the-counter multipurpose ointment which is nationally sold at CVS, Walgreens and Costco. For the third year in a row, Calmoseptine® Ointment has the distinguished honor of being named #1 pharmacist recommended brand for incontinence by U.S. News & World Report (See our website calmoseptine.com for more information). Calmoseptine Ointment is currently exported to 15 countries.

We have an OTC Pharmaceutical General Plant Manager position available in our state of the art manufacturing facility. This opportunity is for a motivated individual that is very knowledgeable in managing all aspects of compounding and filling OTC ointments or creams with a solid understanding of Good manufacturing Practice Standards.

The OTC Pharmaceutical General Plant Manager will lead, organize, and manage personnel and activities in all compounding and filling activities to ensure compliance with FDA cGMP regulations, Standard Operating Procedures, local, state, and federal regulations, and safety practices. The OTC Pharmaceutical General Manager will oversee the compounding, filling, quality control, quality assurance, facilities, maintenance and repair departments to ensure consistent execution, quality and improvement of the compounding and filling process. The OTC Pharmaceutical General Manager will have daily correspondence with the owner of the company.

Responsibilities

  • The OTC Pharmaceutical General Manager shall be responsible for ensuring Calmo Manufacturing consistently produces high quality Calmoseptine Ointment.
  • The General Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.
  • Performs, leads and provides direction for all aspects of compounding and filling of Calmoseptine Ointment. Handles raw materials and finished product and ensures records are maintained as required. Performs and ensures standard operating procedures are performed to ensure product quality and to meet current good manufacturing practices (cGMP).
  • Effectively manage tasks associated with daily pharmaceutical manufacturing and filling activities.
  • Nurture a collaborative working environment within the various departments. This includes working with the Director of Quality to ensure that communication is maintained between manufacturing and filling employees and give support to other areas when needed.
  • Create a culture of continuous improvement and provide coaching and mentorship
  • Reports to owner - daily events that have occurred, etc.


Facilities

  • Ensure facility is maintained in a constant state of inspection readiness ensuring that all staff are compliant with cGMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), documents, and records
  • Ensures that only approved documentation and procedures are utilized at all times.
  • Ensure quality and safety requirements are clearly defined, robust processes are in place, and capable employees are properly trained to guarantee compliance with all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA.


Equipment and Inventory

  • Ensure effective inventory management and help to ensure that raw materials and components that are out of specification are rejected. Experience with RAM is a plus.
  • Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
  • Ensure safety throughout operations and identify preventative plans to prevent accidents
  • Ensuring that all equipment, as proscribed through regulation is available and in good working order, including all preventative maintenance is up-to-date
  • Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.


Communication

  • Provide management with routine updates regarding the productivity and efficiency of operations and any potential or developing issues that may arise.
  • Initiate recommendations on purchasing of new pharmaceutical equipment and improvements
  • Performs other job-related duties as required.

Requirements

Position Qualifications

Education / Qualifications / Certifications

  • B.S. degree in Sciences, Engineering, etc., or acceptable equivalent combination of education and experience.
  • 5+ years of pharmaceutical/manufacturing experience, including at least 5+ years with proven management/leadership role
  • Experience with Blue Mountain Regulatory Asset Manager helpful.


Key Requirements

  • Required Work Hours: Mon - Friday 6a-6pm (60+ hours)
  • Strong Mechanical aptitude
  • Technical training and experience to be general manager of a pharmaceutical plant that includes:
  • Strong knowledge of pharmaceutical regulatory requirements, including Current Good Manufacturing Practice, etc. (Global standards such as ICH and PIC/s helpful).
  • Good References Required


Skills Desired

  • Strong organizational, collaborating and verbal and written communication skills
  • Provide technical expertise to resolve manufacturing issues
  • Troubleshoot and identify issues while supporting resolution with outside groups
  • Identify and coordinate repairs, identify and assist with deviations, review batch records, author change requests for improvements.
  • Experience with process development, process transfer, validation
  • Ability to independently manage work, actions and expectations is essential
  • Ability to cope with varied levels of workload and multiple tasks
  • Strong time management and organizational skills
  • Flexible and proactive to meet company needs
  • Self motivated and able to work independently
  • Strong interpersonal and “people” skills

Categories

Posted: 2021-11-24 Expires: 2021-12-25

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OTC Pharmaceutical General Plant Manager

Calmo Manufacturing Inc
Huntington Beach, California 92647

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