What are the responsibilities and job description for the Quality Supervisor - Microbiologist position at Micronova Manufacturing?
Description
The Quality Supervisor – Microbiologist manages the review, update and maintenance of quality practices across the production cycle from product design and procurement to final release of product.
Works as a liaison with all departments, and customers, to deal with issues relating to Quality and conformance issues. Co-ordinates testing with Design and customer advocates to ensure claims relating to product performance are verified and supported with appropriate data. Oversees sanitation requirements and environmental studies and maintains Good Laboratory Practices (GLPs) in documentation and record keeping. Strong leader with solid work ethic in successfully completing tasks by being a dependable, responsible contributor committed to excellence and success.
Duties and Responsibilities
Essential Job Functions
- Environmental Monitoring to determine microbial content of raw materials, in-process and finished products.
- Set up of tests, active testing, reading plates, monitoring activity and trending of results
- Interpret test results and provide disposition/recommendations
- Ensure that appropriate testing procedures are followed, and necessary controls are maintained
- Assure that all materials used and/or products produced/used at Micronova meet the microbiological requirements of Regulatory Agencies.
- Manage efficient collaboration and co-ordination between relevant departments to ensure quality assurance:
- Production Manager/Procurement on developing tests to validate new materials/products
- Production Staff and Quality Unit to ensure that quality procedures are being followed
- Design, Procurement and R & D on developing tests to validate and support claims on new materials and products
- Design, R & D to establish specifications and stability data for new materials and new product designs
- Implement and enforce quality control and tracking programs to meet quality objectives
- Analyze production and quality control to detect and correct problems
- Develop and execute standard operating procedures for production operations
- Determine and implement improvements to the quality process including but not limited to:
- Non-conformance, Audit Findings/Customer Requests/Internal Investigation
- Perform audits and improvement initiatives assuring continued compliance
- Evaluates results and recommends corrective actions when required.
- Oversee audit reports including but not limited to, paper audits, physical audits
- SOP Revisions
- Updates to procedures for best practices
- Response to supplier and customer audits
- NC, corrective actions
- Ensure standard operating procedures are adhered to
- Collaborate with HR to ensure employee is trained and skill levels are adequate for appointed tasks.
- Training and evaluation of employees per Matrix and job duties
- Preparation of training materials (SOPs, PowerPoint presentations)
- Active training
- Documentation of trainings
- Equipment cleaning and sanitizing procedures
- Correspond with customers and supplier including but not limited to:
- Quality Agreements
- Product quality and use
- Paper audits
- Questionnaires
- Inform Quality Unit of any anomalies in processing of product including return, scrap, re-work relating to:
- Raw materials
- Machines
- Packaging
- Process (planned and un-planned deviations)
- Personnel
- Ensure that above incidents are correctly recorded on corresponding work order or required documentation
- Ensure proper disposition of all semi and finished good including product returns and inspection/dispositions of all 3rd party goods receipts
- Non-conformance Investigations
- Root Cause/Preventive Action/Corrective Actions
- Production Quality Monitoring and Inspection including but not limited to:
- Incoming Raw Material Inspections and Approvals
- Receipt of Incoming Raw Materials and Testing of specific products
- Quality/Production - walk through of Production area to update on corrective actions, areas of improvement and overall update of manufacturing areas with Quality.
- Work Order Review – weekly review of random work orders provided by Production.
- Creation and review of Certificates of Analysis for Micronova products as well as received products from suppliers
- Pest Control company with activity and following up on responses
- Internal Lab Testing Results and analysis of testing data based on:
- Internal investigations
- Customer related questions
- On-going product durability testing
- 3rd Party request
- Maintain records of all tests performed, methods used and final disposition according to Standard Operating Procedures.
- Maintain laboratory equipment service and calibrations
- Maintain a clean and organized work flow by monitoring steps of the process
- Contributes to team effort by accomplishing related results as needed
- Adhere to following the Quality Management System (QMS) in accordance with ISO 9001 standards
- Show ownership to maintain an effective Quality Management System (QMS) in accordance with ISO 9001 standards
Note: This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.
Qualifications
Minimal Qualifications include:
- Formal education and experience in Microbiology
- Strong analytical and communication skills
- In depth knowledge of raw materials, formulations, microbiological test procedures
- Ability to develop and improve laboratory procedures
- Strong leader with solid work ethic in successfully completing tasks by being dependable, responsible contributor committed to excellence and success
- Demonstrated problem solving skill with ability to identify root causes and implement corrective action.
- Logical, structured thinker who critically assesses his/her own performance
- Eager to meet challenges and quickly assimilate new concepts
- Strong organizational skills
- Knowledge of quality systems and standards
- Ability to communicate with management and vendors
Preferred Qualifications include:
- Insight of process improvement techniques
Working Conditions
Physical and Ergonomic Requirements
- This job operates in a professional office environment.
Reports to
- Director of Operations
Direct Reports
- Quality Technician
Job Type & Details
- Full-time
- Exempt
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Ability to Commute:
- Torrance, CA 90505 (Required)
Ability to Relocate:
- Torrance, CA 90505: Relocate before starting work (Required)
Work Location: In person