QA Specialist II (GMP Pharma)

Shift:

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

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.

Compensation: $50,000.00 - 55,000.00 per year

Job Responsibilities

* **QMS Maintenance and Improvement:** 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).
* **Documentation Control:** Manage and control quality-related documents, including standard operating procedures (SOPs), work instructions, and forms, ensuring they are current, accurate, and readily accessible.
* **Internal Audits:** 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.
* **Corrective and Preventive Actions (CAPA):** 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.
* **Training and Education:** Assist in providing quality-related training to laboratory personnel, ensuring understanding and adherence to quality policies and procedures.
* **Supplier Qualification:** Participate in the qualification and monitoring of key suppliers and vendors to ensure the quality of outsourced services and materials.
* **Data Review and Trending:** Review laboratory data and quality metrics for trends, identifying potential issues and recommending solutions.
* **Regulatory Compliance:** Stay current with applicable industry regulations and standards, ensuring the QMS remains compliant. Assist in preparing for and participating in external audits and inspections.
* **Continuous Improvement:** Actively participate in continuous improvement initiatives, proposing and implementing solutions to enhance efficiency, quality, and compliance.
* **Collaboration:** Work collaboratively with various departments, including laboratory operations, client services, and management, to resolve quality issues and promote a quality-focused environment.

Job Qualifications

* **Education:** Bachelor's degree in Chemistry, Biology, Environmental Science, or a related scientific field.
* **Experience:** Minimum of 3-5 years of progressive experience in a quality assurance role within an analytical laboratory setting (environmental, pharmaceutical, or food testing preferred).
* **Technical Skills:**
* 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).
* **Soft Skills:**
* 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.
* **Certifications (Preferred):** ASQ Certified Quality Auditor (CQA) or other relevant quality certifications.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.