What are the responsibilities and job description for the Quality Associate position at Innovacyn Inc.?
Quality Associate
Innovacyn, Inc. is a portfolio company of Burlingame Industries, a privately held, family-owned global enterprise. Our success since 1969 is built upon putting the success of our employees first and foremost. Innovacyn is an ISO 13485 certified company, and a leading designer and manufacturer of unique hypochlorous chemistries for human and animal wellness applications and environmental disinfection needs.
The Quality Associate has the primary responsibility over batch record review, purified water testing and incoming inspection of raw materials and components. Additional duty includes keeping training records up to date and production lot retain storage management. The Quality Associate conducts compliance review of quality system records including but not limited to the review of SOPs, protocols, reports, data and records generated to support the manufacturing and distribution of product. The individual must treat people with respect, work ethically, with integrity, accept responsibility for own actions and uphold organization vision, values, and objectives. Must work well with others and be able to work in a fast-paced environment.
Qualifications
- B.S. in a science related discipline or equivalent work experience
- Ability to comprehend written instructions, manuals, and standard operating procedures
- Must have the ability to write legibly for proper completion of batch records
- Ability to complete simple math tasks to verify the accuracy of batch data involving calculations
- Experience working in an ISO certified or FDA regulated manufacturing environment preferred
- Experience working in a Quality department
- Working knowledge of a cGMP environment preferred
- Attention to detail and accuracy
- Strong communication, organizational, and multi-tasking skills
- Proficient in Microsoft Word and Excel
- Maintain flexibility as it pertains to work hours and schedule, including possible overtime on weekdays and weekends when required
- Ability to maintain objectivity and work constructively with others to resolve noncompliance issues related to company’s quality system
- Good driving record to operate the company vehicle for the transportation of product sample retains.
Essential Functions
The following job duties include identifying and reporting all nonconformities and deviations in a timely manner to Quality and Regulatory management team as well as assisting in the root cause investigation using CAPA and NCMR processes.
Production Quality Assurance
· Quality check daily batch record documentation for accuracy before approving for release into production
· Review formulation, bottling & packaging process data in the batch record to ensure that all intermediates and finished products meet specifications prior to the release into finished goods inventory
· Steward batch data entry through company electronic system
· Conduct periodic inspection of operator practices and production processes. Report objective observations to the upper management regarding team adherence to cGMP requirements
· Generate special purpose protocols to support data collection as assigned
Raw Material Inspection & Water Testing
- Test raw materials and components per incoming inspection procedures and methods.
- Coordinate with Purchasing to make certain that certificate of compliance, certificate of analysis and safety data sheets are obtained from vendors.
- Preform testing of the water system per Innovacyn Standard Operating Procedures (SOP).
Product Retains, Training and Audit
- Collect and transport retains to the designated locations within and outside of the facility on a regular basis. This activity involves operating a company vehicle.
- Maintain an up-to-date database and logbook that reflects accurate inventory.
- Organize and maintain the inventory including removal and disposal per Innovacyn guidelines and procedures.
- Assist and participate in providing formal quality system training to quality and manufacturing staff members.
- Assist in internal and external audits.
- Other duties as assigned.
If you meet the qualifications, submit resume for review.
Job Type: Full-time
Pay: $17.00 - $23.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Experience level:
- 5 years
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- In-person
- Office
Work Location: In person
Salary : $17 - $23