Quality Assurance

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

SCOPE OF POSITION

The Computer System Validation Engineer or Specialist is well-organized, detail-oriented, self-motivated, and a team player. Under the direct supervision of Management, the Computer System Validation Engineer or Specialist leads, designs, performs, reports, and coordinates to complete projects and validation activities on GXP computer systems used in the pharmaceutical and medical device industry for domestic and international markets. Must be familiar with standard concepts, practices, and procedures within a pharmaceutical manufacturing facility. An exceptional degree of creativity and flexibility is required.

PRIMARY RESPONSIBILITIES

  • Development and execution of the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks, and network components)
  • Development and execution of qualification and validation of documentation and activities Information Systems software. This includes qualification/validation plans, test strategies, test scripts, application migration records, and summary reports
  • Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state).
  • Responsible for the requalification and revalidation for computer systems.
  • Perform quality audits on validation / qualification documentation.
  • Manage and successfully execute several validation projects concurrently by teaming up with internal and external contacts with minimal supervision.
  • Development and/or update intra and interdepartmental procedures, policies, and supporting documentation associated with computer system validation.
  • Reviews and assesses vendor-supplied computer system validation documentation for alignment with internal company requirements. Generates client gap protocols where deficiencies are identified.
  • Reviews and summarizes the output of completed executed computer system scripts for vendor-supplied documentation.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

  • High-level competency with the management, development and/or validation of GXP computer systems of ERP (ASCTrac®), EQMS, or LIMS including automation systems such as SCADA and BMS is preferred.
  • Computer system validation experience with cGMPs and/or GLPs, and Quality Systems is preferred.
  • Knowledge of current regulatory requirements/guidelines in the area of process validation and computer system validation.
  • Knowledge of current FDA regulations, pharmaceutical GMPs (21 CFR 11, 210, 211 and 820), and/or ICH regulations.
  • Excellent user knowledge of GAMP Computer System Principles
  • Be a leader and able to guide the project team in all areas of compliance.
  • Be able to work independently, be self-motivated, and organized.
  • Be able to complete assignments in a team-oriented environment.
  • Be able to work in a fast-paced environment while supporting multiple and changing priorities.
  • Excellent user knowledge of Microsoft products (e.g., Excel, Word, Outlook, PowerPoint, and Project, Teams)
  • Strong technical writing and attention to detail required.
  • Excellent verbal and written communication skills.
  • Willing and capable of working on various projects with cross-functional teams at all levels within the organization.
  • Work hours may include off-shifts, weekends, and holidays.

QUALIFICATIONS

  • Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field.
  • 3 to 5+ years of computer system validation experience is required.

PHYSICAL REQUIREMENTS

  • Lift up to 20 lbs.
  • Stand for extended periods (up to 4 hours).
  • Walk between facilities.
  • Push/pull cart holding up to 150 lbs.
  • Climb ladders up to 10 feet.
  • Bend, squat, reach, or crawl around equipment/machinery.
  • Able to work at heights up to 20 feet.
  • Walk up and downstairs.
  • Work extended hours beyond 8 hours.
  • Type documents (protocols, procedures, etc) for extended hours.

 

WHAT WE OFFER!

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

SCOPE OF POSITION

The Validation Engineer is well-organized, detail oriented, self-motivated, and a team player. Under the direct supervision of Management, the Validation Engineer leads, designs, performs, reports, and coordinate to complete projects and validation activities on equipment and processes used in the manufacture of regulated over-the-counter (OTC) drug ophthalmic products for domestic and international markets.  Individual must be familiar with standard concepts, practices, and procedures within a pharmaceutical manufacturing facility.  An exceptional degree of creativity and flexibility is required.

PRIMARY RESPONSIBILITIES

  • Knowledge of pharmaceutical liquid manufacturing operations and knowledge of regulatory requirements/guidelines in the area of validation.
  • Responsible for risk analysis, process validation, cleaning validation, and equipment qualification required for new products, processes, and equipment in addition to any changes to existing products, processes and equipment.
  • Manage and successfully execute several validation projects concurrently by teaming up with internal and external contacts with minimal supervision.
  • Capable of meeting project objective timelines by successfully planning, tracking and executing validation projects that may potentially cover all three shifts of manufacturing.
  • Excellent verbal communication and technical writing skills with strong attention to detail
  • Create and/or update intra and interdepartmental procedures, policies, and supporting documentation.
  • Demonstrate problem-solving and troubleshooting skills.
  • Stay current with validation regulatory requirements.
  • Knowledge of FDA regulations, pharmaceutical GMPs (21 CFR 210, 211 and 820), and/or ICH regulations.
  • Must have prior knowledge of instrumentation and/or calibration processes.
  • Assist with intradepartmental projects and activities as necessary.
  • Ability to work in a fast paced environment while supporting multiple and changing priorities
  • Prepares all protocols and reports for validation work.
  • Provides input, reviews, and approves User Requirements Specifications (URS).
  • Provides input on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and Commissioning protocols.
  • Coordinates all validation activities by constant communication with affected departments and personnel.
  • Execute, oversees, and reviews validation area processes and procedures.
  • Troubleshoot and resolve issues with equipment and processes as it impacts the validated state
  • Controls and organizes all validation documents.
  • Ensures equipment used for qualification purposes is properly maintained and calibrated.
  • Create and/or update intra and interdepartmental procedures, policies, and supporting documentation
  • Competent with GMP’s concepts, practices and procedures as defined in 21 CFR Parts 210, 211, and 820.
  • Assist with technical writing and any other activities assigned by the Corporate Validation & Technical Manager.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

  • Ability to work independently be self-motivated and organized.
  • Ability to complete assignments in a team-oriented environment.
  • Excellent user knowledge of Microsoft Excel, Word, Outlook, Power Point, and Project
  • Technical writing and strong attention to detail required.
  • Excellent verbal and written communication skills.
  • Experience with aseptic processes preferred.
  • Hands-on experience in qualification of one or more of the following: refrigerators, freezers, incubators, autoclaves, liquid filling machines, isolators, ISO classified environments, utilities (steam, water, compressed air), media fills, sterilization processes, environmental monitoring, process control systems, cleaning validation, process validation.
  • Willing and capable of working on various projects with cross-functional teams at all levels within the organization.
  • Willing and capable of assisting in the process, equipment, and cleaning development along with managing associated validation activities.
  • Ability to work in a fast-paced environment while supporting multiple and changing priorities.
  • Work hours may include off-shifts, weekends, and holidays.

QUALIFICATIONS

  • Bachelor’s in Chemical or Biological Sciences/Engineering preferred.
  • 5+ years of Quality Assurance experience in the pharmaceutical manufacturing environment.
  • Knowledge in aseptic manufacturing process is preferred.

PHYSICAL REQUIREMENTS

  • Lift up to 20 lbs.
  • Stand for extended periods (up to 4 hours).
  • Walk between facilities.
  • Push / pull cart holding up to 150 lbs.
  • Climb ladders up to 10 feet.
  • Bend, squat, reach, or crawl around equipment/machinery.
  • Able to work at heights up to 20 feet.
  • Walk up and down stairs.
  • Work extended hours beyond 8 hours.
  • Type documents (protocols, procedures, etc) for extended hours.

BENEFITS

  • 401(k)
  • Dental Insurance
  • Disability Insurance
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Referral Program
  • Vision Insurance

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

Please send your resume to

hr@kc-ph.com