F253
Located in Birmingham, AL
Pay: $20-$24/hr
Job Full Description
Job Summary:
This position is responsible for performing Quality Assurance activities with a focus on risk management, report writing, and deviation handling. The critical skills for this role are demonstrable technical writing abilities and a drive towards continuous improvement. The position will support in carrying out time sensitive projects. This position reports directly to the Director of Quality.
Here's What Your Day-to-Day Looks Like:
Essential Duties and Responsibilities
- Conducts risk assessment and root cause analysis using Quality tools (FMEA, gap analysis, etc.)
- Familiar with regulatory guidance and proposed changes as they apply to 503b manufacturing facilities.
- Assists with studies to inspect, test, and evaluate the reliability of manufacturing processes, products, and equipment.
- Performs trending on key metrics to support Product Annual Review and Quality Management Review.
- Supports the CAPA program. Works cross-functionally to complete Corrective and Preventative Actions (CAPAs) in a timely manner.
- Conducts CAPA effectiveness checks and documents results.
- Attends all required meetings and provides clear, professional verbal and email communication.
- Performs other duties, such as writing deviations, as
Skills and Experience Required
- Bachelor’s degree in scientific discipline/engineering strongly preferred.
- At least three years(preferred) of practical experience of in a Quality role in an FDA regulated company.
- Experience working to cGMP guidelines and demonstrated expertise in variety of the field’s concepts, practices, and procedures.
- Preferred: Continuing education such as ASQ or Six Sigma certification.
- Experience working with Production or Manufacturing.
- Must exhibit excellent verbal and written communication skills.
- Must exhibit excellent attention to detail.
- Exceptional computer skills (data entry, Microsoft Office products, Adobe, inventory management software, eQMS).
- Ability to work as part of a small team in a fast-paced environment.
- Possess time management skills and the ability to work independently, multitask, complete projects according to deadlines.
Additional Notes
- Must be willing and able to gown for ISO 8 area.
Schedule & Pay:
- FULL TIME; Mon-Fri, 8:00am-5:00pm
- Willingness to work overtime if needed, including weekends
- $20-24/hr
Here's What Makes YOU a Great Fit:
- Able to physically do the work and meet physical requirements (willing to work outside in the elements, get dirty, deal with smells, etc.)
- Must have reliable and timely transportation
- Good work ethic; punctual & dependable; take pride in your work
- Good teamwork and communication skills
- Steel toed boots recommended but not required
- Drug-free; background check
Job Location: Birmingham, AL
APPLY TODAY!
What Makes Express Employment Professionals Different?
Express Employment Professionals - Birmingham, is a local employment agency that has been helping people find great jobs since 2006. We focus on helping people find long-term positions at some of the best companies in the area. Every week we are actively working with 150+ companies in the Birmingham and surrounding areas.
Immediate Benefits of working with Express:
- Weekly Pay
- Medical, Dental, Vision, Short-Term Disability, and Life Insurance
- 401(K) Savings Plan
- Holiday Pay
- Referral Bonuses
- Employee Assistance Program (counseling & expert advice in many stressful areas)
- Free Online Training
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Birmingham (South), AL
3348
200 Cahaba Park Circle
Suite 130
Birmingham, AL 35242
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