What are the responsibilities and job description for the Quality Assurance Associate position at BodyBio Inc.?
Overview:
The Quality Assurance Associate role is to handle market complaints and oversee quality in our facilities (warehouses and production plants, etc) including Quality Control activities.
Responsibilities:
Handling Market Complaints
Document, investigate, and participate in market complaints received from customers.
Prepare market complaint investigations with scientifically sound write-ups through coordination with different departments and stakeholders.
Write appropriate responses to customers as needed addressing their concerns
Prepare trend reports for market complaints received from customers.
Overseeing Quality
SOP/Training
Write, revise, and provide training to new and existing employees for Standard Operating Procedures, testing specifications, protocols, and reports as needed.
- Manage Training software, enter training records, and trend all BodyBio employees' traiining
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- Production/Warehousing
Inspect procedures and logbooks to ensure they are efficient and comply with regulations.
o Assist in monthly internal audits.
- Record all data and results in specified forms, records, or log books with accuracy.
- Assist in reviewing and ensuring all completed manufacturing records are free from error before product release.
- Assist in product release activities after thorough review of testing data and batch manufacturing records.
- Assist in internal and external audits with management guidance.
- Ensure and maintain retained samples.
- Pulling of samples.
- Organizing retain cages.
Oversee and Inspect production lines throughout production runs.
o Help to eliminate errors/ Line Clearance.
· Test and monitor the facility environments for microbial contaminants.
o Water system, Air monitoring, Drains, Hoses and Sinks.
Inspect, test, and release cleaned equipment
o Working closely with sanitation personnel.
Maintain the trending data/results generated from the environmental monitoring and cleaning equipment verifications.
Send raw materials, components, finished products, and stability samples to appropriate 3rd party laboratories.
· Maintain a clean working environment.
- Assist with filing of QC and QA documents.
- Assist with cleaning/method validation studies.
- Support in handling and disposing of product returns.
- Discover opportunities for continuous improvement.
- Participate in other duties as assigned by the Quality management.
Skills:
- Associate’s degree in science-related field
- 3-5 years experience in a QA role at an FDA-regulated Pharmaceutical, Nutraceuticals, or Food industry company
- Critical thinking and ability to write market complaint investigations
- Basic knowledge of Microsoft Office
- Ability to work closely with co-workers
- Effective communication and Organizational skills
- Strong problem-solving/troubleshooting skills
- Ability to multi-task in a fast-paced environment
- Ability to travel at least 20% of the time.
If you have a passion for maintaining high-quality standards and ensuring product excellence, we encourage you to apply.
Job Type: Full-time
Pay: $22.00 - $24.00 per hour
Expected hours: 39 per week
Benefits:
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Parental leave
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
Experience level:
- 3 years
Schedule:
- Day shift
- Monday to Friday
Work setting:
- In-person
- Manufacturing facility
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
- Day Shift (Preferred)
Ability to Commute:
- Millville, NJ 08332 (Required)
Ability to Relocate:
- Millville, NJ 08332: Relocate before starting work (Required)
Work Location: In person
Salary : $22 - $24