Cleanroom DC Quality Technician - 1st Shift

ABEC Inc; Bethlehem (Northampton County); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading supplier to the biopharmaceutical manufacturing industry is seeking a DC Quality Technician. This role involves following quality control procedures for Disposable Containers and ensuring compliance with industry standards. Candidates should possess a high school diploma and relevant experience, with opportunities for growth in a dynamic environment.

Benefits

10 Paid holidays and 3 weeks vacation time

Medical, dental and vision insurance

Company paid life insurance

Generous 401K plan (40% match)

College tuition benefit program

Employee Referral Program

Qualifications

• Minimum one-year relevant experience in quality assurance.
• Experience with GMP manufacturing and documentation is a plus.
• Ability to read tape measure and perform simple math.

Responsibilities

• Conduct in-process inspections and prepare quality documentation.
• Ensure compliance with quality standards and guidelines.
• Participate in continuous improvement initiatives.

Skills

Attention to detail

Self-motivated

Basic computer proficiency

Education

High school diploma or GED equivalent

Job description

Description

First shift is 6am-2:30pm.

ABEC is at the forefront of innovation in our industry,offering highly differentiated products and services driving exceptional growth.As we expand to meet increased demand and new opportunities, we seek talented individualsto join our team and support our continued success. We’re in a significant growth phase, with multiple key roles open across our organization.If you’re qualified for multiple positions, we encourage you to applyfor the role that aligns most with your skills and experience.

Company Overview:

ABEC is a leading supplier to the biopharmaceutical manufacturing industry. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.

Benefits include:

• 10 Paid holidays and 3 weeks vacation timeper calendar year
• Medical, dental and vision insurance (benefits start day 1)
• Company paid life insurance
• Generous 401K plan (40% match)
• College tuition benefit program
• Employee Referral Program

Position Summary:

DC Quality Technician follows Custom Single Run (CSR) Disposable Containers (DC) operations procedures and process to support the overall quality assurance plan. This role supports quality improvement throughout the DC Operations. The technician will execute the required quality steps in manufacturing DCs and have the chance to work in a fast-paced environment on industry leading equipment. This role participates as cross-functional team member within assigned goal-oriented team responsibility.

Responsibilities:

• DC is a right first-time product. The candidate must understand fully the associated quality acceptance criteria and willing to drive for continuous improvement.
• Ability to carry out procedures in accordance with Standard Operating Procedures (SOPs) and Guidelines (GDLs)
• Conduct in-process inspections and prepare reporting documents as required during manufacturing and packaging of DCs.
• Inspection of incoming materials & components, ABEC manufactured items, and assembled systems to ensure conformance to established quality standards and all related quality documentation requirements.
• Ensure accurate and complete development of all required quality-related documentation.
• The candidate must be willing to adhere to all associated standards and procedures associated with working in a classified clean environment.
• Perform necessary data entry to process accepted materials and components into ERP system, conduct associated quality data analysis, and execute the improvement plan.
• Conduct operations in a safe manner and be fully committed to maintain a clean and safe working environment.
• Will play an active role in identifying and driving Continuous Improvement (CI) opportunity.
• Execute other tasks as assigned.
• Ability to travel when required.

Requirements

• High school diploma or GED equivalent.
• Basic computer proficiency.
• Aptitude with blueprint reading.
• Ability to wear all personal protective equipment & cleanroom gowning equipment.
• Self-motivated.
• Attention to detail.
• Must be capable of maintaining a clean and safe working space.
• Ability to read tape measure and perform simple mathematical equations.
• Minimum one-year relevant experience.
• Awareness of and prior experience with implementing Continuous Improvement (CI) a plus.
• Prior Lean/Six Sigma experience a plus.

Desired attributes:

• Certified Quality Inspector, (CQI) / Certified Quality Technician (CQT).
• Experience with GMP manufacturing and documentation.
• Experience working in an ISO Cleanroom Environment.
• Extensive knowledge of industry’s legal rules and guidelines.