Quality Engineer

6AM City, LLC; False Pass (AK); On-site; USD 58,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

6AM City, LLC is seeking a Quality Assurance Specialist for an on-site role in New Cumberland, PA. You will support Operations and Quality, ensuring compliance with FDA regulations and cGMP, and drive continuous improvement across quality systems.

The contract-to-hire position offers a competitive pay range, comprehensive benefits, and opportunities to lead CAPA activities, deviations, internal and external audits, and document control across multiple cross-functional teams.

Qualifications

• Regulated pharmaceutical/biotech QA experience.
• Knowledge of FDA regulations in quality systems.
• Understanding of cGMP requirements.
• CAPA investigation and corrective actions.
• Document control with accurate records.
• Experience with audits (internal/external).
• Deviation management and resolution.
• Strong documentation and attention to detail.
• Analytical skills and data interpretation.
• Bachelor's degree in Life Sciences or related field.

Responsibilities

• Support Operations and Quality functions by ensuring adherence to applicable regulatory requirements and internal quality standards.
• Partner with the Quality team to investigate, assess, and respond to quality events in a timely, compliant manner.
• Contribute to the maintenance and improvement of the quality management system and documentation.
• Drive process improvements to enhance product quality and regulatory compliance.
• Manage and control quality documentation, including creation, revision, review, and archiving of controlled documents.
• Support CAPA activities, including root cause analysis and corrective actions.
• Participate in deviation management with documentation and tracking.
• Assist in preparation for internal and external audits.
• Apply cGMP principles in daily work and promote a culture of quality.
• Collaborate with cross-functional teams to integrate quality into processes.

Skills

Quality assurance experience

FDA regulations

cGMP

CAPA processes

Document control

Audit participation

Deviation management

Analytical skills

Attention to detail

Bachelor's degree in Life Sciences

Education

Bachelor's degree in Life Sciences or a technical field

Job description

Job Description

Job Description

Job Title: Quality Assurance SpecialistJob Description

This role supports Operations and Quality by ensuring compliance with regulatory requirements and driving continuous process improvements within a pharmaceutical or biotechnology environment. The Quality Assurance Specialist partners closely with the Quality team to respond to quality events, enhance operational processes, and maintain robust quality system standards in alignment with FDA regulations and cGMP requirements.

Responsibilities

• Support Operations and Quality functions by ensuring adherence to applicable regulatory requirements and internal quality standards.
• Partner closely with the Quality team to investigate, assess, and respond to quality events in a timely and compliant manner.
• Contribute to the maintenance and improvement of the quality management system, ensuring documentation and processes meet regulatory and company standards.
• Drive process improvement initiatives that enhance product quality, operational efficiency, and regulatory compliance.
• Manage and control quality documentation, including creation, revision, review, and archiving of controlled documents.
• Support CAPA (Corrective and Preventive Action) activities, including root cause analysis, implementation of corrective actions, and effectiveness checks.
• Participate in deviation management by documenting, tracking, and helping resolve deviations in accordance with established procedures.
• Assist in preparation for and participation in internal and external audits, ensuring records and processes are audit-ready.
• Apply cGMP principles in daily work and promote a culture of quality and compliance across the site.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into operational processes and continuous improvement efforts.

Essential Skills

• Quality assurance experience in a regulated pharmaceutical or biotechnology environment.
• Demonstrated knowledge of FDA regulations and their application to quality systems and operations.
• Understanding of cGMP requirements and ability to apply them in day-to-day activities.
• Experience with CAPA processes, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Hands-on experience with document control practices, including managing controlled documents and maintaining accurate records.
• Familiarity with audit processes, including preparation for and participation in internal or external audits.
• Experience in deviation management, including documentation, tracking, and resolution of deviations.
• Strong documentation skills with meticulous attention to detail and accuracy.
• Strong analytical skills with the ability to interpret data, identify trends, and propose improvements.
• Bachelor's degree in Life Sciences or a technical field.

Additional Skills & Qualifications

• Experience working with medical devices is a plus, in addition to experience in pharmaceutical or biotechnology settings.
• Ability to collaborate effectively with cross-functional teams, particularly Operations and Quality.
• Strong organizational skills with the ability to manage multiple tasks and priorities in a regulated environment.
• Clear written and verbal communication skills for documenting quality activities and interacting with stakeholders.
• Continuous improvement mindset with a focus on enhancing quality systems and operational processes.

Work Environment

This is an on-site, first-shift position working Monday through Friday at a facility with approximately 50 employees. The environment is a regulated pharmaceutical or biotechnology site that emphasizes compliance, collaboration, and a strong quality culture. Team members work closely across Operations and Quality, using established quality systems, documentation tools, and cGMP practices to support reliable and compliant operations.

Job Type & Location

This is a Contract to Hire position based out of New Cumberland, PA.

Pay and Benefits

The pay range for this position is $42.00 - $55.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and d