Validation Associate

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

BioLife Laboratory Validation Associate is responsible for the management and execution of project and system qualifications, validations, re-qualifications, and revalidations of laboratory facilities, equipment, utilities, and processes. Ensures compliance with regulations and proper documentation 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 (CLIA), and applicable Takeda and BioLife policies, procedures, and quality initiatives. Position may focus on equipment, process, or control systems validation.

ACCOUNTABILITIES

• The development and completion of documentation on protocols, including test cases and final reports.
• Manage documents and follow up on validation projects, including new equipment selection, acquisition, installation, and use, facility/system/process improvements, modifications, and additions, and computer-based systems and software.
• Organizes and performs the logging and archiving of validation documents.
• Assist in the creation of validation protocols and requalification programs.
• Coordinate/perform the test activities necessary to execute the validations.
• Review/summarize the results and conclusions of the validations.
• Coordinate any software control activities used in the manufacture, testing, approval, or documentation of the product.
• Performing technical failure analysis on processes/products not meeting specifications.
• Developing statistical process control programs to monitor processes.
• Reporting on trends to reduce product/process variability.
• Apply statistical analysis and design of experimental approaches to process development activities.
• Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• May determine methods and procedures for new assignments and may provide guidance to lower-level personnel.
• Stays current with federal, state, local, company-specific all other applicable regulations.
• Provides interpretation and application of regulatory requirements concerning validation activities.
• Participates in audits of laboratory operations, documents audit findings, and reports results to Laboratory Quality Assurance Manager and Director of Laboratory Operations.
• Works with the laboratory management team to prepare for and host internal and external auditors. Assists the laboratory management team in ensuring the timely closure of audit observations.
• Assists with and/or advises on laboratory procedure development and implementation as requested or necessary to support continuous improvement. Performs annual review and or validation of SOPs as needed.
• Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to effectively perform laboratory quality assurance functions.
• Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
• Performs revisions to Standard Operating Procedures as assigned.
• Participate 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.)
• Other duties as assigned.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong knowledge and understanding of applicable regulatory and quality requirements and standards required.
• Strong written, verbal, and 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 required.
• Proficiency in the use of personal computers and software programs, including Microsoft Word, Excel, and PowerPoint.
• Result-oriented with the ability to adapt to changing priorities.
• Walking, standing, observing others performing work assignments.
• Ability to work in an office/production environment.
• Potential exposure to blood-borne pathogens requires some work tasks to be performed while wearing gloves.

Leadership

• Fairness
• Honesty
• Perseverance
• Putting the patient at the center
• Building trust with society
• Reinforcing our reputation
• Developing the business

Decision-making and Autonomy

• Must be able to determine the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions.

Interaction

• Interfaces with employees of various educational backgrounds and levels within the company. Must be able to communicate effectively with all these various business partners.

Complexity

• Walking, standing, observing others performing work assignments.
• Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and leaning.
• The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree from an accredited college/university in a biomedical or technical discipline (Chemical, physical, biological, clinical lab science, medical technology, engineering, computer science, or mathematics)

Desired:

• Bachelor's degree from an accredited college/university in medical technology.
• Minimum of two years professional or technical experience in a laboratory, blood services, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
• Experience writing/approving validation plans preferred.
• Familiarity with quality assurance and regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment is preferred.
• Prior experience with auditing and/or inspection processes preferred.
• Knowledge of Laboratory Information Management Systems (LIMS) validation preferred.

ADDITIONAL INFORMATION

• Periodic Travel may be required
• FLSA Classification (US): Exempt

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - GA - Social Circle - Baxter Pkwy

U.S. Base Salary Range:

$70,000.00 - $110,000.00

The estimated salary range reflects an anticipated range for this position . T he actual base salary offered may depend on a variety of factors , including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based e mployee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s . 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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Baxter Pkwy

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes