Pace® Labs · 4 hours ago
QA Specialist II (GMP Pharma)
Oakdale, MN
Full-time
Onsite
Mid Level
$50K/yr - $55K/yr
3+ years expPace® Labs is committed to advancing health and safety through innovative scientific practices. The QA Specialist II plays a crucial role in ensuring laboratory quality and compliance with regulatory standards while promoting continuous improvement initiatives.
Executive Office
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
Qualification
Required
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
Preferred
ASQ Certified Quality Auditor (CQA) or other relevant quality certifications
Benefits
Comprehensive benefits program
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
ID theft
Company
Pace® Labs
Pace® works with organizations of all types, providing the science to ensure our air, water, therapies, and more are safe for use.
1001-5000 employees
H1B Sponsorship
Pace® Labs has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase