Quality Coordinator - 2nd Shift at Biolife Plasma Services Careers

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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

Q uality

A ssurance

activities

at the BioLife

Testing

L aboratory

by

performing the following duties.

ACCOUNTABILITIES:

• Reviews
  
  testing,
  
  quality
  
  control,
  
  and
  
  other'
  
  testing
  
  reports
  
  for
  
  accuracy,
  
  completeness
  
  and
  
  compli
  
  ance
  
  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
  
  func
  
  tions. (5%)
• Adheres
  
  to
  
  the
  
  laboratory
  
  quality
  
  control policies,
  
  document
  
  all
  
  quality control
  
  activities, instru
  
  ment
  
  and
  
  procedural calibrations and
  
  maintenance performed. (5%)
• Identifies
  
  problems
  
  that
  
  may
  
  adversely
  
  affect
  
  test
  
  performance
  
  or
  
  reporting
  
  of
  
  test
  
  results
  
  and
  
  eit
  
  her
  
  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
    
    perfor
    
    mance specifications.
• Performs
  
  review
  
  and
  
  or
  
  validation
  
  of
  
  SOPs
  
  as
  
  needed.
  
  (5%)
• Participates
  
  in
  
  operational
  
  excellence
  
  initiatives
  
  and
  
  projects to
  
  drive
  
  a
  
  culture
  
  of
  
  continuous
  
  im
  
  provement
  
  to
  
  achieve site
  
  operational
  
  excellence goals
  
  (Including
  
  but
  
  not
  
  limited
  
  to
  
  5S,
  
  Value
  
  Stream Mapping, and Kaizen. (5%)
• Other
  
  duties as
  
  assigned.

DIMENSIONS AND ASPECTS:



Technical and Functional Line Expertise:

• 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.

Leadership

• Integrity
• 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 to product quality when testing deviations occur, contain the situation and Implement preventive actions.

lnteraction

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

Complexity

• 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.
• The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this role.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:



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.

Desired:

• 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

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. Hourly Wage Range:



$18.85 - $29.62

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. 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 . click apply for full job details