Quality Tech 2

Job Description

Job Description

Benefits Offered :

Medical

Dental

Vision

401K with company match

PTO

11 Paid Holidays

4 / 10 schedule Monday - Thursday (Maybe asked to work overtime, weekends, or Holidays depending on business needs)

PM Shift 4 PM - 2 : 30 AM

Job Summary :

The Quality Technician II plays a key role in ensuring product integrity and regulatory compliance throughout the manufacturing process. This position is responsible for performing in-depth inspections, testing, and documentation of raw materials, in-process components, and finished goods. The role supports quality initiatives by enforcing GMP standards, executing internal audits, resolving non-conformances, and implementing corrective actions. Acting as a mentor and indirect lead to junior quality staff, the Quality Technician II collaborates cross-functionally to uphold quality standards, improve processes, and contribute to continuous improvement efforts. This position requires strong analytical skills, attention to detail, and the ability to work independently in a dynamic manufacturing environment.

Job Duties & Responsibilities :

• Assures consistent quality and oversees inspection, physical test methods and procedures.
• Enforces good manufacturing practices and systems by verifying processes and reviewing documentation.
• Achieves quality by contributing information and preparing and completing action plans; identifying and resolving problems; determining system improvements; implementing change, enforcing policies and procedures.
• Accomplishes quality objectives; analyzes variances and initiates corrective actions.
• Supports quality processes by documenting evidence, identifying critical control points and preventative measures by monitoring procedures and verification of procedures.
• Assists in writing and updating quality procedures.
• Maintains and improves product quality by surveillance audits, company policies, systems, procedures, and compliance.
• Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Responsible for conducting testing procedures on equipment during manufacturing processes to ensure that products comply with quality standards.
• Focuses on various procedures throughout the manufacturing process; Inspection of finished goods to find defects, check weights, etc.
• Oversees the rework process by inspection and physical test methods and procedures.
• Pulling incoming raw and finished samples for testing, inspect and verify incoming and outgoing product and paperwork to ensure that products comply with quality standards.
• Oversees and updates in-process product inspection standards.
• Maintains product quality by enforcing quality policies and procedures.
• Accurately update quality logs; Lab submission, skip lot testing, MRB and expired products.
• Sample, perform and document thorough examinations of all materials and finished products.
• Conduct and report internal audits and evaluations.
• Implement and improve quality control operating procedures.
• Supports the management of outside lab testing, material review, and release procedures.
• Administers a timely turnaround on OOS, NCR, or CAPA activities especially relating to incoming raw materials and finished product prior to release.
• Performs in-process or incoming material testing in-house as needed on equipment housed within the sampling laboratory.
• Acts as an indirect lead of other quality technicians to coach and monitor performance as needed to report up to quality management.
• Can act in place of quality tech I position to cross cover areas when department might be shorthanded.
• Can act as a provisional backup for Quality Supervisor if Director or Assistant Manager assign.
• Other projects as assigned.
• Adheres to cGMP within production areas of facility, monitors and enforces other team members adherence to requirements.
• Possesses a higher level of understanding of cGMP requirements and has the ability to coach and train fellow employees on appropriate compliance with standards.
• Responsible for monitoring and reporting on consumable items and inventory, equipment calibration and performance, and other items as needed to maintain an effective sampling / testing lab and process.
• As a higher-level employee within the quality unit, this position facilitates interdepartmental cooperation for the purposes of effective production and continuously improving a companywide culture committed to high standards of quality in all aspects of manufacturing.
• Maintain a clean and safe work environment.

Qualifications :

• High School Diploma or GED Preferred. Equivalent experience will be considered on a case-by-case basis.
• Previous work experience in quality control or other related fields
• Strong attention to detail
• Strong analytical and critical thinking skills
• Excellent written and verbal communication skills
• Proficient in Microsoft Office
• A proficiency in reading and writing English to meet FDA record keeping requirements.
• Competency in adding, subtracting, multiplying, dividing, calculating percentages, and determining the simple mathematical formulas to be used.
• Frequent walking, standing, bending, and reaching throughout the shift.
• Ability to lift up to 20 pounds.
• Compliance with GMP environment and PPE requirements.

4 / 10 schedule 4 PM - 2 : 30 AM Monday - Thursday