Shire Quality Assoc I in Social Circle, Georgia
The Quality Associate I is 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 (CLIA), and applicable BioLife policies, procedures and quality initiatives. The Quality Associate I performs quality assurance activities of BioLife Testing Laboratory by performing the following duties personally or through subordinates.
Essential Responsibilities :
1) 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.
2) Ensures laboratory compliance with all federal, state, local and company specific regulations related to quality of product and employee safety.
3) Participates in audits of laboratory operations, documents audit findings and reports results to Quality Manager II and Director of Operations.
4) 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.
5) Reviews and approves final release of laboratory data.
6) Adheres to the laboratory quality control policies, documents all quality control activities, instrument and procedural calibrations and maintenance performed.
7) Identify problems that may adversely affect test performance or report of test results and either correct the problems or immediately notify the laboratory management.
8) Follow established corrective action policies and procedures whenever test systems are not within established acceptable levels of performance.
9) Document all corrective actions taken when test systems deviate from established performance specifications.
10) Reviews and track non-conformances and quality control data as required by laboratory quality assurance procedures. Immediately communicates significant concerns identified to the laboratory Quality Managers or Quality Supervisor to ensure that questionable test results are not released. May stop operations when product safety may be compromised.
11) Works with laboratory management team to prepare for and host internal and external auditors.
12) Assists laboratory management team to ensure timely closure of audit observations.
13) Facilitates development and implementation of laboratory procedures as required to support continuous improvement.
14) Performs annual review and or validation of SOPs as required.
15) Prepares data for Management Review Meetings, Quality Assurance Staff Meetings and Monthly Laboratory Staff Meetings.
16) Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
17) Performs revisions to Standard Operating Procedures as assigned.
18) Assist in training staff in certified areas of review.
19) Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence and goals (including but not limited to 5S, Value Stream Mapping, Kaizen and Developing Defect Free Processes (DDFP).
Job Scope : Location – US/PR/Canada
Education and Experience
Minimum degree required: Bachelor’s degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology)
Associate degree from an accredited college/university in laboratory science or medical laboratory technology.
Preferred degree: Bachelor’s degree or higher from an accredited college/university in medical technology.
Minimum two years professional or technical experience in a laboratory, blood services or pharmaceutical manufacturing, including significant exposure to quality assurance and regulatory requirements affecting that discipline or activity.
Technical/professional certification preferred.
Experience writing/approving validation plans preferred.
Prior experience with auditing and/or inspection processes preferred.
Knowledge, Skills and Ability:
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
Ability to articulate clearly and conduct oral presentations.
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.
Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
Ability to work in an office/production environment.
Ability to adapt to changing priorities
Walking, standing, observing others performing work assignments.
Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, 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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.