QA Complaints Associate

Department

Quality Assurance

Job Title

Complaints Associate

FLSA Status

Exempt

Reports To

QMS Supervisor

1. Role Purpose:

Primary responsibility is to provide technical writing support to Operations and to assist Operations management in ensuring that all activities are being performed in accordance with relevant cGMPs, SOPs and GDPs (ALCOA) and to participate in creating, writing and reviewing documentation related to the Manufacturing, Packaging and Engineering departments. To assist in Quality Management system such as complaint investigation, Corrective and Preventive actions.

2. Key Duties & Responsibilities:

• Perform monitoring of departmental activities to ensure they are being performed in compliance with SOPs, GMPs, GDPs and ALCOA. Document, correct and report any issues.
• Assist with the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Participate in developing, writing and reviewing qualification documents and updating SOP’s and Forms.
• Participate in complaint investigation activity and provide extensive support in conducting activity related to complaint investigation.
• Design, develop and implement databases to track key project deliverables and resource allocation within Packaging and Manufacturing and update on an ongoing basis.
• Initiate and manage process improvement activities based upon gathered data or as a result of investigations or other activities.
• Assist with and perform investigation and technical writing activities in the Manufacturing and Packaging areas.
• Participate in the management of Change Control activities associated with Operations.
• Monitor and facilitate training of departmental personnel including one-on-one training, group training and on-the-job training and in managing relevant training documentation.
• Provide assistance when needed with the preparation, execution or review of Qualification Protocols and reports.
• RDPA- Initiation, receiving and disposition
• Retain Sample – Inspection for complaints and annual product review
• Random walkthroughs of operations and facility areas and review procedures and practices (ALCOA) are being compiled with.
• Other duties as delegated.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

B.S. or higher degree from an accredited college/university (preferably in a scientific discipline)

Experience Requirement

At least 0-5 years of job-related experience or equivalent preferred

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Excellent English writing, spelling, punctuation, and grammar skills
• Ability to interpret complex data and draw valid conclusions
• Proficient in the use of spreadsheets, databases, presentation, and word processing software. Basic Microsoft Office proficiency is expected.
• Strong interpersonal skills and the ability to effectively work and communicate with cross-functional teams
• Strong organizational and multi-tasking abilities
• Self-motivated, work well independently and as a team player and re-prioritize workload as required
• Continuous working knowledge of applicable cGMP guidelines
• Continuous working knowledge of applicable DEA regulations

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A