Quality Assurance

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

Current Openings

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

SCOPE OF POSITION:

 

Assures quality products and processes by establishing and enforcing quality standards. Quality Assurance Assistant assist in managing all quality related investigation programs. Ensure Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and support customer and regulatory audits.

 

PRIMARY RESPONSIBILITIES:

 

  • Assist Annual Internal Quality Audit (IQA).
  • Assist in trend analysis for Quality Assurance (QA) Department.
  • File Medical Device Report (MDR) with FDA.
  • Assist in regulatory (FDA) and customer audit.
  • Review Incident Reports (IR) from all departments and issue investigation as necessary.
  • Assist in performing and reviewing Change Controls (CC) for various Quality Assurance (QA) and Quality Control (QC) standard operating procedures (SOPs).
  • Assist in quarantine/release of quarantined products.
  • Investigate customer complaints and inquiries and properly document all findings.
  • Assist in managing all investigations program and issue investigation number to responsible department.
  • Assist in verifying all CAPA issued due to investigations and recommendation from the Management.
  • Maintain Supplier Approval List
  • Answer to quality related customer inquiries relating to the products.
  • Release of In-process Materials
  • Review Packaging, Filling and Compounding records
  • Assist with New Employee training, Orientation and maintain Signature Log
  • Perform Retention Room Annual Inspection Report

 

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:

 

  • Pharmaceutical experience is highly desired and will be given precedence.
  • Proficient in Microsoft Excel, Microsoft Word, and PowerPoint for data management.
  • Experience with Microsoft GP

 

Job Type: Full-time

 

Schedule:

  • Monday to Friday

 

Work Location:

  • One location

 

Benefits:

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

 

Experience:

  • Documentation Control: 1 year (Required)
  • ASC system: 1 year (Preferred)
  • Quality Assurance: 1 year (Required)

 

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 an experienced Inter-department Coordinator to conduct the following.

 

BASIC FUNCTIONS:

 

  • Understand the packaging schedule generated by the planner.
  • Understand the line clearances for the packaging lines.
  • Interact with the Production Leads, DCC, Warehouse and QA personnel.
  • Coordinate and prepare the staging of printed materials, brite stock and batch record documents according to the packaging schedule generated by the planner.
  • Understand the reconciliation of printed materials and brite stock.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

 

Duties:

  • Request the packaging batch record(s) and inventory forms from QA/ DCC department in advance according to the packaging schedule.
  • Request next MO record based on the production packaging schedule.
  • Special Request
  • Request next Lot number of circle toppers, barrel lens case & flat lens.
  • Request blank inventory form for components when needed.
  • Request items from the Warehouse in advance to avoid any delays to the production lines per the packaging batch record(s) and inventory forms.

 

Responsibilities:

  • Need to be able to reconcile Packaging Records and assist production in the reconciliation process when and if production line leads are not available.
  • Will aid in the closing of packaging line clearance for production when and if the production line leads are not available.
  • Reconciliation of packaging Records, Brite Stock, Print materials, and In-Process Materials Inventory.
  • Report any discrepancies on printed materials or brite stock bottles to the production supervisor & QA inspectors.
  • Notify DCC when there’s a discrepancy on the batch record or on the printed material inventory so it could be corrected before staging the batch to avoid delays to the packaging lines.
  • Stage and maintain specified Key Performance Indicator’s (KPI’s) for manufacturing orders to ensure sustainability of Production.
  • Coordinate and update the following departments; DCC, Warehouse, QA, Supply Chain with findings/changes affecting the packaging schedule.
  • Perform walk-throughs on staging area for overall cleanliness and any safety concerns.
  • Must know how to utilize pallet jacks and operator electric forklifts.
  • Responsibilities are not limited to the content mention above.

 

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:

 

  • Complies and adheres to existing and new regulations.
  • Complies with all company policies and procedures.
  • Comply with all company safety policies and procedures to ensure a safe and healthy environment.
  • Able to have flexible time and work overtime (OT) to support manufacturing.

 

QUALIFICATIONS:

 

  • Pharmaceutical experience is highly desired and will be given precedence.
  • Proficient in Microsoft Excel, Microsoft Word, Microsoft Dynamics GP and File Maker Pro for data management.

 

MINIMUM REQUIREMENTS:

 

  • High school diploma or equivalent
  • 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.

 

Job Type: Full-time

 

Work authorization:

  • United States (Required)

 

Work Location:

  • One location

 

Benefits:

  • 401(k)
  • 401(k) Matching
  • Dental Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Referral Program
  • Vision Insurance

 

Experience:

  • High school or equivalent (Preferred)

 

This job is:

  • A job for which military experienced candidates are encouraged to apply.

 

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 a QA Inspector to conduct the following.

 

PRIMARY RESPONSIBILITIES:

 

  • Review production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
  • Supports the most quality functions and potential issues.
  • Assists in the writing of detailed reports and analyze quality data.
  • Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of the information contained in all documents, document files, databases, and documentation systems.
  • Ensures completeness and accuracy of the information contained in all documents, document files, databases, and documentation systems.
  • Creates cGMP labels and reviews and reconciles cGMP label generation.
  • Manage change control program and training program. Assign number and file Change Control package.
  • Issue, file, and distribute all company-controlled documents. Update SOP manuals and table of the content index for each SOP manual.
  • Ensure all controlled document’s revision and effective date are expedited accordingly.
  • Maintain all official manufacturing documentation, quality control documentation, and validation packages.
  • Issue batch lot numbers for various drug and medical device products.
  • Review, release, and reconcile printed materials (labels and unit carton) for accuracy.
  • Print official copies of the documents to record current data as a request of the departments.
  • Check printed material for new product artwork.
  • Check Printed Material Inspection Sheet and attach Printed Material Inventory Sheet.
  • Update documentation database as needed.
  • Responsibilities are not limited to the content mention above

 

QUALIFICATIONS:

 

  • Pharmaceutical experience is highly desired and will be given precedence.
  • Proficient in Microsoft Excel, Microsoft Word, Microsoft Dynamics GP and File Maker Pro for data management.
  • 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

 

Experience:

  • GMP (Good Manufacturing Practice): 1 year (Required)
  • Pharmaceutical Manufacturing: 1 year (Required)
  • Quality Assurance: 1 year (Required)

 

Education:

  • High school or equivalent (Required)

 

Work authorization:

  • United States (Required)

 

Shifts:

  • Mid-Day (Required)
  • Evening (Required)
  • Graveyard (Required)

 

Benefits:

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

 

Pay Frequency:

  • Bi weekly or Twice monthly

 

Schedule:

  • Monday to Friday
  • Weekends required
  • Day shift
  • Night shift
  • Overtime
  • 8 hour shift

 

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 for a QA Associate in Document Control.

 

PRIMARY RESPONSIBILITIES:

 

  • Data entry, handling customer complaints
  • Reviews production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
  • Supports most quality functions and potential issues.
  • Assists in the writing of detailed reports and analyze quality data.
  • Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of the information contained in all documents, document files, databases, and documentation systems.
  • Ensures completeness and accuracy of the information contained in all documents, document files, databases, and documentation systems.
  • Creates cGMP labels and reviews and reconciles cGMP label generation.
  • Manage change control program and training program. Assign number and file Change Control package.
  • Issue, file, and distribute all company-controlled documents. Update SOP manuals and table of the content index for each SOP manual.
  • Ensure all controlled document’s revision and effective date are expedited accordingly.
  • Maintain all official manufacturing documentation, quality control documentation, and validation packages.
  • Issue batch lot numbers for various drug and medical device products.
  • Review, release, and reconcile printed materials (labels and unit carton) for accuracy.
  • Print official copies of the documents to record current data as a request of the departments.
  • Check printed material for new product artwork.
  • Check Printed Material Inspection Sheet and attach Printed Material Inventory Sheet.
  • Update documentation database as needed.
  • Responsibilities are not limited to the content mention above

 

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.
  • 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

 

Experience:

  • Microsoft Dynamics GP: 1 year (Preferred)
  • Microsoft Excel: 1 year (Preferred)
  • Quality Assurance: 1 year (Required)
  • Manufacturing: 1 year (Preferred)
  • Customer Service Skills: 1 year (Preferred)

 

Education:

  • High school or equivalent (Required)

 

Location:

  • Pomona, CA 91768 (Preferred)

 

Additional Compensation:

  • Store Discounts

 

Benefits offered:

  • Paid time off
  • Parental leave
  • Dental insurance
  • Health insurance
  • Healthcare spending or reimbursement accounts such as HSAs or FSAs
  • Retirement benefits or accounts
  • Employee discounts

Status: Full Time, Non-Exempt

Reports to: QA Supervisor (DCC)

Department: Quality Assurance

 

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 QA Inventory Control Associate to conduct the following.

 

SCOPE OF POSITION

 

Responsibilities of the Quality Assurance – Inventory Control include receiving, inspecting and issuing of Raw Materials and Printed Material for manufacturing, compounding, and fill batch records. Perform Cycle Count Process to ensure inventories are accurate.

 

PRIMARY RESPONSIBILITIES

 

  • Receive incoming Raw Material and Printed Material.
  • Check Printed Material Inspection Sheet and attach Printed Material Inventory Sheet.
  • Check printed material for new product artwork.
  • Review and inspect printed materials (labels and unit carton) for accuracy.
  • Stage raw material and printed material for filling and packaging operation.
  • Performs Cycle Count Process to ensure accuracy of inventory
  • Supports most quality functions and potential issues.
  • Creates cGMP labels and reviews and reconciles cGMP label generation.
  • Daily use of warehouse management system (WMS): ASCTrac®
  • Monitor, identify and resolve issues
  • Ensure quality operations in the warehouse
  • Operate fork-lift equipment or other types warehouse machinery
  • Maintain clean and orderly work environment
  • Responsibilities are not limited to the content mention above

 

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.
  • Able to have flexible time and overtime (OT) to support manufacturing.

 

QUALIFICATIONS

 

  • Pharmaceutical experience is highly desired and will be given precedence.
  • Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.
  • Proficient in Microsoft Excel, Microsoft Word, Microsoft Access, Microsoft Dynamics GP and File Maker Pro for data management.
  • Follow proper safety procedures
  • Possess strong teamwork skills
  • Ability to lift up to 50 pounds

 

MINIMUM REQUIREMENTS

 

  • Associates degree preferred.
  • Preference: Normally receives no instruction on routine work and general instructions on new assignments.         

Status: Full Time

Reports to: QA Manager

Department: Quality Assurance

 

SCOPE OF POSITION

 

Assures quality products and processes by establishing and enforcing quality standards. Quality Assurance Complaint Handling assist in managing all quality related investigation programs. Ensure Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and support customer and regulatory audits.

 

PRIMARY RESPONSIBILITIES

 

  • Investigate customer complaints and inquiries and properly document all findings.
  • Contact consumers via telephone, email.
  • Update Customers regarding specific customer complaints.
  • Request information from Customers and consumers.
  • Assist Annual Internal Quality Audit (IQA).
  • File Medical Device Report (MDR) with FDA.
  • Assist in regulatory (FDA) and customer audit.
  • Assist in performing Change Controls (CC) for Quality Assurance standard operating procedures (SOPs).
  • Assist in trend analysis for Quality Assurance (QA) Department.
  • Assist in managing all investigations program and issue investigation number to responsible department.
  • Maintain Supplier Approval List
  • Contact Suppliers to ensure we have updated Supplier information
  • Request for CoA, CoM, Audit reports, certification etc. from Suppliers.
  • Assist in Release of In-process Materials
  • Assist in Review Packaging, Filling and Compounding records as needed
  • Assist with New Employee training, Orientation and maintain Signature Log
  • Perform Retention Room Annual Inspection Report
  • Responsibilities are not limited to the content mentioned above

 

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

 

  • Pharmaceutical experience is highly desired and will be given precedence.
  • Proficient in Microsoft Excel, Microsoft Word, and PowerPoint for data management.
  • Experience with Microsoft GP, ASC Sofware

 

MINIMUM REQUIREMENTS

 

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

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

Please send your resume to

hr@kc-ph.com