Quality Control Specialist I

Description

Location: Franklin Indiana  

Principal Function: 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.

Essential Duties and Responsibilities: Duties include, but are not limited to:

• 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
  
   

Competencies: To perform their jobs successfully, all employees working at B2S Life Sciences should demonstrate the following competencies:

• Organizational Support
• Teamwork
• Adaptability
• Ethics
• Interpersonal Skills
• Analytical – Synthesizes complex or diverse information;      Collects and researches data; Uses intuition and experience to complement      data; Designs workflow and procedures.
• Quality and Productivity – Demonstrates      accuracy and thoroughness; Looks for ways to improve and promote quality;      Applies feedback to improve performance; Monitors own work to ensure      quality; Meets productivity standards; Respects deadlines; Strives to      increase productivity.
• Oral and Written Communication – Speaks clearly      and persuasively in positive or negative situations; Listens and gets      clarification; Responds well to questions; Demonstrates group presentation      skills; Participates in meetings; Writes clearly and informatively; Edits      work for spelling and grammar; Presents numerical data effectively.
• Problem Solving – Identifies and resolves      problems in a timely manner; Gathers and analyzes information skillfully;      Develops alternative solutions; Works well in group problem solving      situations.
• Safety and Security – Observes safety and security      procedures; Reports potentially unsafe conditions; Uses equipment and      materials properly.

Requirements

Education and/or Experience: 

• 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.

Other Skills and Abilities: The following skills and abilities are required:

• 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.
• 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.

Physical Demands:

• Ability to stand less than 1/3 of the time.
• Ability to walk less than 1/3 of the time.
• Ability to sit more than 2/3 of the time.
• Ability to talk or hear from 1/3 to 2/3 of the time.
• Ability to lift 20 lbs. less than 1/3 of the time.

Work Environment:

• The work environment is in an office/laboratory environment.
• Travel up to 5% percent of the time.
• Frequent use of a computer is necessary.
• This position requires working independently, as well as part of a team.
• While performing the duties of this job the noise level in the work environment is usually moderately loud and has moderate temperatures.
• Personal protective equipment is required to be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves.
• This position requires the use of all general office equipment.
• Potential exposure to pathogens.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.