Position Summary
The Sr Quality Assurance Inspector performs audit review on each batch record to ensure completeness and compliance before final release of products.� This audit to assure the product has been manufactured in accordance with established quality standards.� Sr. Quality Assurance Inspector is responsible to retain all batch records per retention procedure.�
This role is 2nd shift (2:45 pm to 11:15 pm, Monday thru Friday) and is 100% onsite at our Southington, CT location.�
Essential Duties & Responsibilities
- Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version)
- Execute final product release via iFactory / Oracle system
- Access to Oracle Installed Base to update serial device information
- Provides Manufacturing / MQA support to detect quality risks
- Verify that the records documented are within the corresponding procedures
- Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment
- Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements.� These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
- File and retain batch records in controlled area per retention procedure
- Ability to troubleshoot and work in a team environment
- Other activities related to the position
Knowledge, Skills & Qualifications
- Excellent Mathematical knowledge
- Good knowledge in records filing
- Good computer knowledge
- Ability to comprehend both verbal and written instructions � � � � � � � � � �
Education and Experience
- Must be at least 18 years of age
- High School Diploma or GED required
- Experience with medical devices/pharmaceutical GMPs preferred
- Minimum of 2 years in a FDA regulated manufacturing environment
Physical Requirements and Work Environment
- While performing the duties of this job, the employee is regularly required to talk, hear and communicate on phone and through email.
- While performing the duties of this job, the employee is regularly required to sit which is mainly on the computer with some standing during shift
- Must be able to repetitively move and lift objects of up to 20 lbs
- Typically requires travel less than 5% of the time
