Quality Assurance Technician

Position: Quality Assurance Technician (5pm-5am)
SUMMARY The Quality Assurance Technician is responsible for ensuring product quality and compliance through in-process monitoring and verification of manufacturing operations. This role performs routine quality checks, including line audits, lot code verification, and product inspections, and identifies, documents, and escalates any defects or non-conformances.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

ESSENTIAL DUTIES AND RESPONSIBILITIES (include but are not limited to the following)
Perform in-process quality checks in production such as lot code verification, line audits, or product inspections and record results. Identify, record, and escalate any defects or non-conformances found during audits.

Execute cleaning and changeover verifications to confirm production teams have followed applicable standard operating procedures (SOPs) and ensure equipment is suitable for use.

Support validations and new product development by following validation or pilot protocols and ensuring all appropriate samples and data are collected.

Manage and support the completion of rework in production.

Contain and escalate any non-conformances that may present during production operations. Collect data and notify the appropriate teams to ensure affected material is isolated and immediate corrective actions are implanted where applicable.

Review and sign off on run reports in Manufacturing Execution System (MES) to ensure in-line checks are completed fully.

Support audit readiness and participate in internal and external audits as needed.

Contribute to continuous review and improvement of processes to ensure consistent, efficient, and effective practices. Make suggestions regarding procedures, standards, and equipment to facilitate work and maintain product quality.

Serve as a liaison between production and the quality department.

Firm understanding and compliance with company’s Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
Display and promote company values (ASPIRE: Attitude, Safety, Passion, Integrity, Relationship, and Evolve)
Regular attendance

Other duties as assigned

REQUIRED

SKILLS AND ABILITIES

Strong attention to detail

Outstanding interdepartmental and customer service skills

Highly motivated

Ability to work in fast paced, rapidly changing, and regulated environment

Excellent planning and organizational skills

Ability to identify problems when they arise and notify appropriate personnel

Exhibit sound and accurate judgment

Ability to work effectively across departmental teams

Strong computer literacy skills

EDUCATION AND/OR EXPERIENCE Associates degree in a related field preferred.

A minimum of 2+ years’ experience in a manufacturing and/or quality related field preferred

Working knowledge of GMPs and quality documentation practices

PHYSICAL REQUIREMENTS / WORKING ENVIRONMENT Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Sit an average of 2 hours per day Stand an average of 10 hours per dayWalk an average of 5 to 6 hours per day Required Movements:

Bend/Stoop:
Frequently (5 to 10 times per hour)
Reach above shoulder level:
Occasionally (1 to 4 times per hour)
Weight Carried:

Up to 10 lbs:
Occasionally (1 to 4 times per hour)11 to 30 lbs:
Rarely (1 to 2 times per day)31 to 50 lbs:
Rarely (1 to 2 times per day)
Weight Lifted:

Up to 10 lbs:
Occasionally (1 to 4 times per hour)11 to 30 lbs:
Rarely (1 to 2 times per day)31 to 50 lbs:
Rarely (1 to 2 times per day)
Hands Used for Repetitive Action:

Simple/light grasping (both hands):
Frequently (5 to 50 times per hour)
Firm/strong grasping (both hands):
Frequently (5 to 50 times per hour)
Fine dexterity (both hands):
Frequently (5 to 50 times per hour)
Job requires being around moving machinery and equipment

Job requires wearing personal protective equipment as necessary

Personal Protective Equipment

Required:

Ear protection for noise as necessary

Safety glasses when in required areas

Nitrile gloves when in contact with raw material or finished product, or when specified

Slip resistant shoes

Potential Physical Exposures:

Noise
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