QA Specialist II (GMP Pharma)

Pace® Analytical Services•Oakdale, MN

3d•$50,000 - $55,000

About The Position

The QA Specialist II at Pace Analytical Services, Inc. plays a crucial role in ensuring the quality and integrity of laboratory operations. This position is responsible for supporting the Quality Management System (QMS) through various quality assurance activities, contributing to compliance with regulatory standards, and promoting a culture of continuous improvement within the organization.

Requirements

Bachelor's degree in Chemistry, Biology, Environmental Science, or a related scientific field.
Minimum of 3-5 years of progressive experience in a quality assurance role within an analytical laboratory setting (environmental, pharmaceutical, or food testing preferred).
Strong understanding of Quality Management Systems (QMS) principles and methodologies.
Demonstrated experience with regulatory standards such as ISO/IEC 17025, NELAC, GLP, or GMP.
Proficiency in root cause analysis techniques.
Familiarity with laboratory instrumentation and analytical methodologies.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Excellent written and verbal communication skills, with the ability to clearly articulate complex quality concepts.
Strong analytical and problem-solving abilities.
High attention to detail and accuracy.
Ability to work independently and as part of a team.
Demonstrated ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
Strong interpersonal skills with the ability to build effective working relationships.

Nice To Haves

ASQ Certified Quality Auditor (CQA) or other relevant quality certifications.

Responsibilities

Assist in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with relevant regulatory requirements (e.g., ISO/IEC 17025, NELAC, GMP, GLP).
Manage and control quality-related documents, including standard operating procedures (SOPs), work instructions, and forms, ensuring they are current, accurate, and readily accessible.
Conduct internal audits of laboratory operations, processes, and systems to assess compliance with QMS requirements and identify areas for improvement. Prepare detailed audit reports and track corrective actions.
Investigate and document non-conformances, out-of-specification results, and customer complaints. Facilitate root cause analysis and the development, implementation, and verification of effective corrective and preventive actions.
Assist in providing quality-related training to laboratory personnel, ensuring understanding and adherence to quality policies and procedures.
Participate in the qualification and monitoring of key suppliers and vendors to ensure the quality of outsourced services and materials.
Review laboratory data and quality metrics for trends, identifying potential issues and recommending solutions.
Stay current with applicable industry regulations and standards, ensuring the QMS remains compliant. Assist in preparing for and participating in external audits and inspections.
Actively participate in continuous improvement initiatives, proposing and implementing solutions to enhance efficiency, quality, and compliance.
Work collaboratively with various departments, including laboratory operations, client services, and management, to resolve quality issues and promote a quality-focused environment.