Quality Assurance Tech
8:30 am - 5:00 pm Mon-Fri
$1,000 HIRING BONUS
Perform Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.
Essential Duties and Responsibilities:
Applicable to all levels of position
- Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
- Support Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
- Work order, customer complaints, BOM, specifications, APR
- Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
- Support the Quality System’s Training Program.
- Support documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
- Support protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
- Evaluate responses to Incident reports and perform follow-up with respondents, if needed, to ensure resolution.
- MCER (Monthly CAPA Efficacy Report), CAPA
- Make changes to SOPs, policies, training materials, and other documents in the records management system.
- Assist during regulatory inspections.
- Interface with various Divisions in problem resolution, and continual improvement.
- Support manufacturing failure investigations.
- Communicate effectively with others.
- Maintain a good attendance record.
- Perform work onsite.
- Perform other duties as assigned.
QualityTechnician (Considered Entry Level Position therefore requiring most supervision/mentoring)
Quality Senior Technician
- Perform at an experienced and functional level therefore requiring limited supervision.
- Engage in Professional Development Activities.
Required Education, Knowledge, Skills, Abilities:
- Minimum 1 year experience in an Food and Drug Administration (FDA) regulated manufacturing environment.
- Minimum 1 year experience training in a business setting.
- Minimum 1 year of progressive experience in Quality Assurance .
- Demonstratable strong written and verbal communication skills.
- Excellent organizational skills.
- Proven record of excellent documentation skills.
- FDA & OSHA trained and familiar with current regulations.
- Strong problem solving skills.
- Project management and technical software skills (Excel, Access, etc.) required.
- Work well under pressure and able to prioritize workloads.
- Ability to perform risk assessment.
- Experiece fostering teamwork to get results.
- Well organized and multi-task oriented.
- Ability to work independently on multiple projects.
- Ability to read, write and speak English competently.
Preferred Knowledge, Certifications, Skills, Abilities:
- Worked in pharmaceutical or cosmetic mfg environment.
- American Society for Quality certifications.
- Project management experience.
- Experience training safety, quality and GMPs.
- Primarily office environment – climate controlled.
- Periodic visits to:
- Warehouse environment – some temperature extremes, dust and noise.
- Manufacturing environment - some temperature extremes, dust, noise and wet.
- Potential exposure to hazardous chemicals.
- Requires use of PPE such as safety glasses, hairnets, or gloves.
The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria considered necessary to perform the job successfully. Marianna recognizes that an individual with a disability may require an accommodation to enable him/her to successfully perform a job function. Consideration will be given to reasonable accommodations.