Responsible for the day to day management of the company’s Quality Control and Quality Assurance functions; ensures the maintenance and effective implementation of all necessary Quality Systems, to achieve compliance to all regulatory, quality and customer-related requirements.
Assures appropriate maintenance of all batch-related documentation, as well as the appropriate maintenance of all SOP’s and Work Instructions. Assures inspection and appropriate disposition of all incoming components and raw materials, prior to use in the manufacturing process, as well as the performance of all in-process tests and inspections throughout the manufacturing process.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
- Fully familiar with and applies FDA / cGMP principles in all areas of responsibility on a daily basis.
- Maintains and implements effective Quality Systems that will enhance the company’s ability to ensure that all products and processes meet quality specifications and standards.
- Provides ongoing guidance in promoting and enforcing company quality policies and requirements.
- Assures company-wide QA training sessions for cGMP’s, SOP’s, company requirements, etc. and ensures that QC Inspectors follow appropriate inspection procedures and techniques.
- Assures that issues potentially affecting product quality / compliance are brought to the attention of Sr. Management and are assessed appropriately.
- Interacts with Operations Management and functions as a resource to resolve quality issues.
- Oversees the investigation of internal non-conformances and external customer complaints, in an effort to resolve them in a timely manner and that effective corrective / preventive actions are implemented, when deemed necessary.
- Participates in hosting customer and regulatory audits and develops responses to audit observations.
EDUCATION / EXPERIENCE:
Minimum Bachelor of Science degree.
Ten or more years of Quality Assurance experience in a regulated industry, in a Management (Supervisor or Manager) position.
SKILLS / ABILITIES:
Thorough knowledge of FDA regulations / cGMP’s.
Ability to read, analyze and interpret technical procedures and government regulations; ability to write reports and customer correspondences.
Proficiency with computer and Microsoft Office (Outlook, Word, Excel).
Self-directed and able to work well independently, as well as in a team environment.
Excellent reasoning, problem-solving and math skills.
Ability to effectively articulate quality related issues to all levels of personnel.
Excellent organizational skills, as well as written and oral communication skills.
Employment Type Full-Time; Permanent
Job Function Quality Assurance
Education College Degree
Experience minimum 10 years
Manages Others Yes
Location Hauppauge, NY
Required Travel None
Comprehensive Benefits Package, including 401(k)
We are an equal opportunity employer. Women, minorities, veterans and individuals with disabilities are encouraged to apply.
Exciting opportunity for a Senior Operator / Set-Up Technician. Premier Care Industries is offering a starting hourly salary based on experience and references.
The ideal candidate should have a strong mechanical aptitude.
• Load and unload machine
• Monitor operations of machine and report abnormalities to manager
• Perform setup, maintenance, troubleshooting and change over Packaging lines, Elsner
Machinary, Canaster Line, Ela Pack, Eman Pack
• Follow operational guidelines, perform routine preventive maintenance
• Maintain the cleanliness of the room and machines to prevent contamination
• Document work as required
• Responsible for following safety rules, SOPs and cGMP guidelines
• Other responsibilities as assigned by Senior Management
Skills and Qualifications
• Some experience in setup, maintenance, and troubleshooting equipment
• Knowledge of mechanical working principles of equipment, including mechanical
• Physically able to bend, stoop and squat, stand for long periods of time, lift up to 50 lbs.
• Must be able to speak and read English
Required Education and Experience:
Some experience in setup, maintenance, and troubleshooting equipment
High school diploma or equivalent or higher educational degree
Premier Care Industries
Why Work Here?Premier Care Industries is a rapidly expanding essential business manufacturer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products located on Hauppauge, NY.
Growing company, Wonderful team culture, Great working conditions