Quality Coordinator - 2nd Shift

Takeda • Social Circle, GA

1d • $19 - $30 • Onsite

About The Position

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Takeda offers a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. Every day, our BioLife Testing Laboratories’ mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect will become life-changing medicines for patients in need. Here, a commitment to lab testing quality, customer service to our plasma centers, and most importantly, our commitment to our patients is expected. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Responsible for the operation of the laboratory In accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CUA), and applicable Takeda and BioLife policies, procedures and quality initiatives. Performs Quality Assurance activities at the BioLife Testing Laboratory by performing the following duties.

Requirements

• Strong knowledge and understanding of applicable regulatory and quality requirements and standards.
• Strong written, verbal, personal interaction and communication skills required. Must be able to write concisely and clearly.
• Attention to detail and organizational skills with analytical and problem solving skills.
• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
• Result oriented with ability to adapt to changing priorities.
• Must be able to determine the impact to product quality when testing deviations occur, contain the situation and Implement preventive actions.
• lnterfaces with employees of various educational backgrounds and levels within the company. Must be able to communicate effectively with aH these various business partners.
• Ability to stand up for 6-8 hours
• Ability to lift, carry and pull up to twenty-five (25) pounds
• Walking, standing, observing others perfonning work assignments.
• Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
• Ability to work in an office / production environment.
• Essential: Bachelor's degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,)
• OR Associate degree from an accredited college/university in laboratory science or medical laboratory technology.

Nice To Haves

• Minimum of two years' experience in a professional or technical capacity in laboratory services, blood services, quality, or pharmaceutical manufacturing, Including significant exposure to the regulatory requirements affecting that discipline or activity.
• Technical/Professional certification preferred.
• Prior experience with auditing and/or inspection processes preferred.
• MT or MLT certification from ASCP or other accredited certifying organization preferred

Responsibilities

• Reviews testing, quality control, and other' testing reports for accuracy, completeness and compliance to cGMP requirements to ensure that quality assurance standards and regulatory requirements are met prior to release from the Quality Assurance Department. (70%)
• Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions. (5%)
• Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. (5%)
• Identifies problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management. (10%)
• Follow established corrective action policies and procedures whenever test systems are not within established acceptable levels of performance. Document all corrective actions taken when test systems deviate from established performance specifications. Performs review and or validation of SOPs as needed. (5%)
• Participates in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (Including but not limited to 5S, Value Stream Mapping, and Kaizen. (5%)
• Other duties as assigned.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level