What are the responsibilities and job description for the Quality Control Manager position at HR HealthCare?
Job Details
Job Location: Plant - York, PA
Salary Range: Undisclosed
Description
Summary of position
The Quality Control Manager is responsible for ensuring the organization is operating in compliance with operating procedures, cGMP and other applicable regulations. This position will be responsible for overseeing, managing and motivating a group of quality technicians conducting various quality tasks throughout the facility. At times, the QC Supervisor will be responsible for drafting, implementing and training employees on new SOPs or policies.
Duties & Responsibilities
- Manage & motivate quality technicians to ensure they are conducting required quality tasks in a timely accurate manner
- Assist with establishment and monitoring of quality KPI’s to ensure quality technicians are achieving organizational goals
- Monitor supplier performance as a result of incoming inspections
- Manage Environmental Monitoring (EM), Bioburden, and Calibration programs
- Coordinate all testing activities, including testing conducted by external labs
- Collect quarterly dose audit samples for products sterilized by gamma radiation
- Lead/Assist execution of validation protocols, testing, and allocating resources
- Lead/Assist with test method development activities and coordinating Measurement System Analysis
- Review and approve necessary documentation including production records, incoming inspections, in-process testing, investigations, batch release records, etc.
- Ensure timely release of all materials
- Act as an area leader for 5S program and ensure compliance
- Assist with resolution of quality/manufacturing related CAPAs and NCRs in a timely, efficient manner
- Participate in customer complaint investigations, as necessary
- Draft and implement quality related SOPs, forms and instructions as required
- Conduct routine plant quality meetings communicating critical quality initiatives, concerns, and opportunities for improvement
- Ensure organizational compliance to cGMPs, ISO 13485, and other applicable regulatory and industry standards
- Promote an environment of compliance to internal policies and procedures
- Promote an environment of quality-first mindset
- Participate in third-party or customer audits, as necessary
- Other duties, as assigned
Qualities
- Strong understanding of GMPs
- Able to conduct quality responsibilities in an efficient and timely manner
- Understanding of regulated industry
- Statistical analysis and knowledge
- Understanding of OSHA and manufacturing safety
- Proficient in MS Office products and computers
- Strong communication skills and ability to train / manage others
- Able to lift up to 50 lbs.
- Attention to detail
- Able to prioritize tasks
- Technical writing abilities
- Dependable and timely to work
- Ability to implement and communicate policies
- Energetic team player with a pleasant demeanor
- Constant pursuit of quality
- Flexible with the ups and downs of manufacturing
- Able to work in teams and interact positively with staff
- Clear understanding of the impacts of quality control
Qualifications
Qualifications
- 5-10 years of quality-related experience or equivalent
- Previous management experience required
- Bachelor’s Degree preferred
