Quality Control

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

Current Openings

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

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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 a Entry Level Microbiology Technician.

 

SCOPE OF POSITION

 

Responsibilities of the Microbiology Department include environmental monitoring of controlled (ISO 14644) environments, sterility testing, growth promotion testing, microbial limit testing, purified water testing, and Gram staining. Microbiology Technicians will sample various locations in controlled and uncontrolled environments and monitor bioburden levels throughout facility. They will also test samples and monitor microbial growth.

 

PRIMARY RESPONSIBILITIES:

 

  • Responsible for the microbiological testing and analysis of raw materials, product bioburden, and final product testing required for product release.
  • Perform Environmental Monitoring of controlled environments per ISO 14644 and USP < 1116> monitoring:
  • Viable air sampling
  • Non-viable air sampling
  • Viable surface sampling
  • Perform monitoring of purified water equipment and outlets.
  • Perform testing in support of monitoring and sampling:
  • Growth promotion testing
  • Microbial limit testing
  • Purified water testing
  • Gram staining
  • Morphology identification
  • Log all aspects of testing onto raw data forms and logbooks.
  • Reports out of specifications to Microbiology Supervisor and management for review.
  • Stores and manages raw data folders and logbooks.
  • Assists in day to day maintenance in the laboratory and maintains all the supplies necessary to run the lab efficiently.
  • Performs preventative maintenance of laboratory equipment
  • Trends Environmental Monitoring Data as necessary.
  • Assists with other tasks on a needed basis as necessary.
  • Participate in audits and validations when necessary.

 

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:

 

  • Working knowledge of Microsoft Excel, Microsoft Word, and Microsoft Outlook (email).
  • Complies and adheres to existing and new regulations.
  • Complies with all company policies and procedures.
  • Must be a team player and customer / results oriented.
  • Comply with all company safety policies and procedures to ensure a safe and healthy environment.
  • Able to have flexible time and overtime (OT) to support manufacturing.

 

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

 

Benefit:

  • 401(k)
  • Dental Insurance
  • Health Insurance
  • Paid Time Off
  • Vision Insurance

 

Schedule:

  • Monday to Friday
  • Weekends

 

Experience:

  • Microbiology: 1 year (Required)
  • Purified Water Testing: 1 year (Required)
  • Pharmaceutical Manufacturing: 1 year (Preferred)
  • Environmental Monitoring: 1 year (Required)

 

Education:

  • Bachelor’s (Required)

 

Work Location:

  • One location

 

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 for a Entry Level Chemistry Tech.

 

SCOPE OF POSITION:

 

The responsibilities of the Chemistry Technician include a combination of the following tasks: raw material testing, finish product testing, water testing, maintaining stability program, and overall maintenance / calibration of the laboratory. Assist with customer complaint testing of retention / customer samples and validation projects. Have general understanding of current Good Manufacturing Practices as well as other regulatory requirements. This position may also assist with writing investigations and standard operating procedures including review of test results for final release of product.

 

PRIMARY RESPONSIBILITIES:

 

  • Collect and test samples as required for the raw material testing, bulk sample testing, finish product testing, and water testing including reviewing test results in a timely manner.
  • Test stability samples accordingly to the schedule.
  • Test retention / customer samples from customer complaints.
  • Ensures Quality Assurance programs supporting manufacturing and testing activities to
  • meet appropriate controls and compliance to Good Manufacturing Practices and Good Laboratory Practices.
  • Participate in training, and/or cross-training.
  • Maintain the laboratory inventory of chemicals, instruments, and supplies.
  • Daily log book management and periodic review of all documentation.
  • Participate in new product designs, developments, and validation projects as appropriate.
  • Assists with other tasks on a needed basis as necessary and as assigned by Chemistry Supervisor.

 

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:

 

  • Complies and adheres to existing and new regulations.
  • Complies with all company policies and procedures.
  • Must be a team player and customer / results oriented.
  • Comply with all company safety policies and procedures to ensure a safe and healthy environment.

 

QUALIFICATIONS:

 

  • B.S. majoring in Chemistry or related sciences.
  • Strong attention to detail.
  • Good time management skills.
  • Willingness to learn and develop new skills.
  • Minor experience working in the chemistry laboratory of a pharmaceutical company is preferred, but not required.

 

MINIMUM REQUIREMENTS:

 

  • Preference: Normally receives no instruction on routine work and general instructions on new assignments. Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.

 

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

 

Benefit:

  • 401(k)
  • 401(k) Matching
  • Dental Insurance
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Vision Insurance

 

 

Schedule:

  • Monday to Friday

 

Experience:

  • Chemistry, Manufacturing & Controls: 1 year (Preferred)
  • Pharmaceutical manufacturing: 1 year (Preferred)

 

Work Location:

  • One location

 

Work Remotely:

  • No

Status: Full Time

FLSA: Exempt

Reports to: Director of Quality

Department: Quality

 

SCOPE OF POSITION

 

The Quality Control (QC) Manager is responsible for overseeing the Microbiology and Chemistry Laboratories. This position is responsible for oversight of cGMP operations to ensure that products are tested to comply with the requirements of regulatory filings and eliminate risk due to inadequate safety, quality or efficacy. Provide direction to members of the Quality Control Laboratories performing analytical testing of raw materials, in-process products, final products pre-release and stability testing for all current products based upon sound scientific practice and general laboratory and company policies.

 

DUTIES AND RESPONSIBILITIES:

 

  • Coordinate operations within lab to ensure materials and products are tested, reviewed and approved within the accepted time frames.
  • Interprets data, identifies adverse trends, and provides strategic resolution to technical issues with group. Ensures scientific and compliance-based suitability of analytical methods used for testing materials and products through method transfers and method validations.
  • Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports.
  • Lead microbiology and chemistry validations including but not limited to media fills, cleaning validations, and review of test results for final release of product.
  • Provide effective planning for QC Labs to include required resources, and the maintenance & communication of cycle times.
  • Lead and manage projects which include microbiology and chemistry department support.
  • Ensures investigations related to OOS, unexpected results, or invalids are performed appropriately and within expected timeframes. Ensure investigations are appropriately thorough to identify root causes or potential root causes and prevent recurrence.
  • Supporting QA/QC during FDA audits, and enhancing current laboratory methods and techniques.
  • Experience in leading analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines
  • Other duties as assigned.

 

MANAGERIAL RESPONSIBILITIES:

 

  • Directly oversees the Microbiology and Chemistry team.
  • Carries out managerial responsibilities in accordance with the organization’s policies and applicable state and federal laws.
  • Coach, mentor, lead and manage departmental employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates. Ensure that performance opportunities are proactively managed through the Performance Management system.
  • Responsibilities may also include interviewing, hiring, training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:

 

  • Knowledge and experience of FDA regulations related to the manufacture of drugs and devices.
  • Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.
  • Ability to lead multiple testing sub-groups (Microbiology/Chemistry) to provide testing efficiencies while in full compliance with regulatory requirements.
  • Ability to lead analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines
  • Demonstrate knowledge and experience in sterile (aseptic process) and non-sterile pharmaceutical cGMP manufacturing.
  • Demonstrate knowledge and experience in analytical method development and validations involving HPLCs, UV Spectrophotometry, etc.
  • Demonstrate knowledge and experience working with various equipment HPLC equipment, UV
  • Knowledge and experience of including but not limited to USP, NF, and EP standards and monographs
  • Exhibit flexibility, open-mindedness, and adaptability to changing environments.
  • Complies and adheres to existing and new regulations and complies with all company policies and procedures.
  • Comply with all company safety policies and procedures to ensure a safe and healthy environment.

 

QUALIFICATIONS:

 

  • S. majoring in Microbiology/Biochemistry/Biology or related science.
  • Aseptic (class 100, ISO 5) environmental monitoring and sterility testing experience.
  • Experience in analytical method development and validations involving HPLCs, UV Spectrophotometry, etc.
  • 6+ years of experience in a microbiology/chemistry laboratory of a pharmaceutical manufacturing environment.

 

COMPETENCIES:

 

  • Leadership – Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
  • Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.
  • Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
  • Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

 

PHYSICAL DEMAND & WORK ENVIRONMENT:

 

  • May occasionally lift and /or move more than 15 lbs.
  • While performing the duties of this job, the noise level in the work environment is usually moderate.

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

Please send your resume to

hr@kc-ph.com