Regulatory

Current Openings  |  Please send your resume to hr@kc-ph.com

Current Openings

Please send your resume to hr@kc-ph.com

KC Pharmaceuticals is a Prime Manufacturer of Private Label and Contract Manufacturing Over-The-Counter (OTC) Eye Drops. We also offer Multi-Purpose Solution products to meet your Contact Lens care needs. KC Pharmaceuticals believes in providing a conducive working environment for our employees to realize their full potential, striving for excellence and innovation as the foundation for growth. We are currently hiring an experienced Director of Regulatory Compliance to conduct the following.

 

PRIMARY RESPONSIBILITIES:

 

  • Ensure compliance with FDA and various other regulatory requirements by being involved in daily oversight of current Good Manufacturing Practices (cGMP).
  • Provide the leadership on regulatory strategy and tactics contributing to the achievement of business objectives.
  • Maintain registrations and ensuring regulatory compliance for the company’s commercially marketed products.
  • Oversee documentation efforts to ensure compliance/risk mitigation and process improvement initiatives.
  • Review Packaging Artwork Proofs inside the electronic workflow and approve or reject based upon the accuracy and compliance of all required labeling elements, including but not limited to, country of origin, ingredient listings, warnings and other legal and/or regulatory required labeling.
  • Oversee the regulatory process and reviews all requirements ensuring compliance with regulatory agencies/groups at the Federal and State levels in coordination with other functions and outside vendors.
  • Coordinate and develop cGMP training on-site.
  • Manage timely identification, escalation, and resolution of compliance issues. Alert management of product quality and compliance issues for proper and timely escalation to the Material Review Board (MRB) and Management Review.
  • Manage activities such as product recalls, mock recalls, and internal quality audits (IQA).
  • Provide support to the sales team with product portal submissions to ensure product compliance.
  • Responsible for hosting audits from FDA, other regulatory agencies, and third party customer auditors. Coordinate and author any written responses from the audit report.
  • Review and complete supplier qualifications in a timely manner.
  • Serve as a management representative of the company.
  • Develop a CAPA Effectiveness Program and a Business Continuity Plan.
  • Assist with Technical Writing and any other activities assigned by the President/CEO.

 

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:

 

  • Strong knowledge and experience of FDA regulations related to the manufacture of drugs and devices.
  • Knowledge and understanding of the drug and device development process, quality systems, analytical testing, microbiological testing, stability, and equipment/process validation.
  • Experience in sterile (aseptic process) and non-sterile pharmaceutical manufacturing.
  • B.S. majoring in Microbiology/Biochemistry/Biology/Life Science.
  • 5 + years of quality assurance and regulatory experience in the pharmaceutical manufacturing environment preferably with working knowledge in the aseptic manufacturing process.

 

WHAT WE OFFER:

 

  • Paid Holidays
  • Health, Vision, Dental, FSA and Life Insurance benefit plans
  • 401k
  • Profit-Sharing
  • Paid Vacation and Sick time

 

Job Type: Full-time

 

Experience:

  • FDA Regulations: 5 years (Required)
  • Sterile (aseptic process): 5 years (Required)
  • Regulatory Compliance: 5 years (Required)
  • Pharmaceutical Manufacturing: 5 years (Required)
  • Quality Assurance/Quality Control: 5 years (Required)

 

Education:

  • Bachelor’s (Required)

 

Work authorization:

  • United States (Required)

 

Additional Compensation:

  • Bonuses

 

Work Location:

  • One location

 

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off

 

Schedule:

  • Monday to Friday
  • Day shift
  • 8 hour shift

 

Company’s website:

  • kc-ph.com

 

Benefit Conditions:

  • Only full-time employees eligible

 

Work remotely:

  • No

KC Pharmaceuticals is a Prime Manufacturer of Private Label and Contract Manufacturing Over-The-Counter (OTC) Eye Drops. We also offer Multi-Purpose Solution products to meet your Contact Lens care needs. KC Pharmaceuticals believes in providing a conducive working environment for our employees to realize their full potential, striving for excellence and innovation as the foundation for growth. We are currently hiring an experienced Maintenance Coordinator to conduct the following.

 

Responsibilities include but are not limited:

  • Equipment documentation gathering
  • Spare parts ordering
  • Purchase Order management
  • Inventory management
  • Standard Operating Procedure Development
  • Maintenance planning
  • Maintenance scheduling
  • Training where applicable

 

Desired Skills:

  • Proficient in Microsoft Office
  • Strong written and spoken communication
  • Ability to plan and run multiple projects
  • Cleanroom and aseptic filling training a plus
  • Experience with cMMS and ERP software a plus (Dynamics GP Preferred)
  • Maintenance and Reliability Professional Certification is a plus
  • Multilingual is a plus

 

WHAT WE OFFER:

  • Paid Holidays
  • Health, vision, dental, FSA and life insurance benefit plans
  • 401k
  • Profit-Sharing
  • Paid Vacation and Sick time

 

Job Type: Full-time

 

Experience:

  • Microsoft Office: 2 years (Required)
  • Clerical: 1 year (Required)
  • Maintenance: 2 years (Required)
  • Scheduling: 2 years (Required)
  • Coordinator: 2 years (Required)

 

Education:

  • High school or equivalent (Required)

 

Work authorization:

  • United States (Required)

 

Work Location:

  • One location

 

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off

 

Pay Frequency:

  • Bi weekly or Twice monthly

KC Pharmaceuticals is a Prime Manufacturer of Private Label and Contract Manufacturing Over-The-Counter (OTC) Eye Drops. We also offer Multi-Purpose Solution products to meet your Contact Lens care needs. KC Pharmaceuticals believes in providing a conducive working environment for our employees to realize their full potential, striving for excellence and innovation as the foundation for growth. We are currently hiring for an experienced Maintenance Technician to conduct the following.

 

DUTIES AND RESPONSIBILITIES:

  • Install facility machinery.
  • Perform preventative and predictive maintenance on facility machinery.
  • Troubleshoot and repair facility machinery.
  • Follow standard operating procedures (SOPs) and Job Safety policies.
  • Complete daily maintenance and repair logs.
  • Communicate with production operators and other shift mechanics.
  • Maintain and secure work tools.
  • Clean and maintain work area.
  • Perform a back-up job for the packaging line.
  • Provide on-the-job training to new employees
  • Perform other duties as assigned.

 

COMPETENCIES:

  • Basic reading, writing, and arithmetic skills required.
  • The skill required in one or more of the following areas: HVAC, electrical, mechanical, hydraulic & pneumatic systems, plumbing, carpentry, piping systems.
  • Ability to read and interpret blueprints and schematics.

 

WHAT WE OFFER:

  • Paid Holidays
  • Health, vision, dental, FSA and life insurance benefit plans
  • 401k
  • Profit-Sharing
  • Paid Vacation and Sick time

KC Pharmaceuticals is a Prime Manufacturer of Private Label and Contract Manufacturing Over-The-Counter (OTC) Eye Drops. We also offer Multi-Purpose Solution products to meet your Contact Lens care needs. KC Pharmaceuticals believes in providing a conducive working environment for our employees to realize their full potential, striving for excellence and innovation as the foundation for growth. We are currently hiring for an experienced EHS Coordinator to conduct the following.

Responsibilities include but are not limited:

  • Drive day-to-day compliance with internal EHS standard operating procedures.
  • Prepare and maintain all Environmental and Health/Safety reporting.
  • Develop procedures and training as needed.
  • Facilitate Annual EHS retraining for all site personnel.
  • Assist facilities supervisor in preparation and submittals for all 3rd party permitting.
  • Ensure on-time accurate reporting of all EHS issues.
  • Maintain the OSHA 300 log and other EHS reporting.
  • Support projects in evaluating safety requirements from construction to equipment procurement.
  • Coordinate with HR, Quality, and Production on EHS requests and initiatives.

Desired Skills:

  • Proficient in Microsoft Office
  • Strong written and spoken communication.
  • Ability to plan and run multiple projects.
  • Detail-oriented.
  • Working knowledge of Cal OSHA Standards and EHS regulatory requirements.
  • Experience with CMMS and ERP software a plus (Dynamics GP Preferred).
  • Multilingual is a plus.

Desired Behaviors:

  • Growth mindset – a willingness to learn and challenge existing norms
  • Performance-driven – makes decisions based on data
  • Accountable – has high performance standards and is willing to stand by their work
  • Self-sustaining – Able to direct own daily activities. Brings solutions to the table instead of just challenges

WHAT WE OFFER:

  • Paid Holidays
  • Health, vision, dental, FSA and life insurance benefit plans
  • 401k
  • Profit-Sharing
  • Paid Vacation and Sick time

Job Type: Full-time

Experience:

  • Microsoft Office: 3 years (Required)
  • Manufacturing: 1 year (Required)
  • Coordinator: 1 year (Required)
  • EHS: 1 year (Required)
  • OSHA: 1 year (Required)

Education:

  • Associate (Required)

Work authorization:

  • United States (Required)

Additional Compensation:

  • Bonuses

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Professional development assistance
  • Other

Please send your resume to hr@kc-ph.com

Please send your resume to

hr@kc-ph.com