Quality Control Specialist I

B2S Life Sciences LLC • Franklin, IN

9h • Onsite

About The Position

The Quality Control Specialist I supports the Operations department by being responsible for reviewing laboratory derived data to ensure a high standard of scientific and data integrity for all services and products provided. In addition, the individual in this role assists management in ensuring quality and regulatory requirements for good laboratory practice (GLP) are met, when specified.

Requirements

• Bachelor’s degree (B.A./B.S.) in chemistry, biology, or life sciences; or Associate’s degree (A.A.) in chemistry, biology, or life sciences and 1 year related experience and/or training; or equivalent combination of education and experience is desired.
• Computer software skills including Microsoft Office Suite, Lockbox LIMS, Salesforce, SharePoint, and Paylocity. Other systems may apply when applicable.
• The ability to maintain confidentiality when appropriate.
• The ability to develop positive working relationships and interact effectively with clients and colleagues.
• The ability to prepare reports, Standard Operating Procedures (SOPs), and other documents.
• The ability to analyze and evaluate data, make determinations, and clearly and concisely present findings in oral or electronic formats.
• The ability to communicate complex ideas in a public forum and develop good relationships with the larger business community.
• The ability to perform duties, problem-solve, and exercise independent judgment within established protocols and guidelines.
• The ability to work independently and as a team.
• The ability to manage and prioritize multiple projects simultaneously.
• The ability to interact professionally and constructively with clients, team members, and co-workers.
• The ability to be sensitive to professional ethics, gender, cultural diversities, and disabilities.
• The ability to travel out-of-town on company business and/or attend or speak at conferences and training sessions, if needed.

Nice To Haves

• Working knowledge of Good Laboratory Practice and Good Manufacturing Practice (GLP and GMP) regulatory requirements through 21 CFR Part 11 and Part 58 is preferred.
• Working knowledge of the International Conference on Harmonization (ICH) guidelines is preferred.

Responsibilities

• Serves as QC (Quality Control) Reviewer
• Communicates internally with the Senior QC Analyst (and other stakeholders, as needed) regarding QC status and turnaround time.
• Accurately and thoroughly reviews lab data, including, but not limited to, worksheets, notebooks, raw data, etc.
• Reviews data for errors, incorrect calculations and omissions
• Reviews source data
• Verifies corrections to the data following B2S-SOP-01-003, Good Documentation Practices (GDP) Standard Operating Procedure (SOP), as well as industry standards
• Assists Senior QC Analyst and Management with training and provides updates for GDP and relevant SOPs
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees