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Validation Associate II

BioLife Laboratory Validation Associate II is responsible for qualification and/or validation of equipment, computerized systems, and laboratory processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of laboratory challenges are conducted and process improvements are evaluated / implemented. Ensures compliance with regulations and proper documentation. Presents change controls and protocols to auditors.
RESPONSIBILITIES:
1.Development and completion of documentation on protocols, including test cases and final reports.
2.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.
3.Organizes and performs the logging and archiving of validation documents.
4.Assist in the creation of validation protocols and requalification programs.
5.Coordinate/perform the test activities necessary to execute the validations.
6.Reviews/summarize the results and conclusion of the validations.
7.Coordinate any software control activities used in the manufacture, testing approval, or documentation of the product.
8.Performing technical failure analysis on processes/product not meeting specifications.
9.Developing statistical process control programs to monitor processes.
10.Reporting on trends to reduce product/process variability.
11.Apply statistical analysis and design of experimental approaches to process development activities.
12.Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
13.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
14.Serves as project lead with projects of intermediate scope and cross-functional teams.
15.Mentors and provides leadership to junior team members.
16.Stays current with federal, state, local, company-specific all other applicable regulations.
17.Provides interpretation and application of regulatory requirements concerning validation activities.
18.Support regulatory submissions and regulatory agency inspections as required.
19.Participates in audits of laboratory operations, documents audit findings and reports results to Laboratory Quality Assurance Manager and Director of Laboratory Operations.
20.Works with laboratory management team to prepare for and host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.
21.Assists with and/or advises on laboratory procedure development and implementation as requested or necessary to support continuous improvement. Performs periodic review and or validation of SOPs as needed.
22.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.
23.Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
24.Performs revisions to Standard Operating Procedures as assigned.
25.Supports/Participates in change control management and CAPA systems.
26.Review Prism standard validation plans.
All other duties as assigned.
EDUCATION AND EXPERIENCE:
Minimum Degree Required:
Bachelor 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)
Preferred Degree:
Bachelor degree from an accredited college/university in Medical Technology.
Experience:
+ Minimum of three 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 required.
+ Prior experience with auditing and/or inspection processes preferred.
KNOWLEDGE, SKILLS AND ABILITY:
+ Familiarity with quality assurance and regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment required.
+ Strong knowledge and understanding of applicable regulatory and quality requirements and standards required.
+ Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. 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 ability to adapt to changing priorities.
+ Ability to work independently or in teams.
+ Walking, standing, observing others performing work assignments.
+ Office / Production environment.
+ Occupational exposure to blood borne pathogens.
+ 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, gender identity, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law ? Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Reasonable Accommodations
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.


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