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Quality Control Specialist 2

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Regulatory & Quality Assurance
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1727 Total Views
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
 
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
 
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
 
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
 
Job Summary
QC Specialist 2 performs all routine testing, acts as SME on procedures and processes, trains other analysts, conducts complex nonconformance investigations, participates and acts as SME in quality audits, and leads and participates in cross-functional team efforts.
 
Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 
  • Performs routine testing as needed.
  • May lead one or more analysts.
  • Designs and executes experiments to troubleshoot non-conformances.
  • Generates, performs, and documents laboratory investigations, CAPA’s and non-conformances.  Uses standard root cause determination methods.
  • Reviews/analyzes data with respect to specifications, validity criteria, alert limits.
  • Oversees lab maintenance duties.
  • Process equipment and equipment calibrations.  Review and enter calibration certificates into equipment tracking system.  Create and process new equipment and equipment records.
  • Participates in quality audits (internal, third party).
  • Initiates and leads document change control activities.  Able to create/revise documents (SOPs, QSs, TPs).
  • Coordinates testing within work cell.  Communicates closely with planners/QA on product release priorities and issues.
  • Works closely with Scientists on method transfer (NPD).  Performs and documents process validations.
  • May act as lead trainer for work cell.
  • May lead department team or cross-functional team.
  • Assists in software and hardware upgrades, including validation and executing test protocols.
  • Assist in generating, performing and documenting equipment validations.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
  • Interpersonal skills
  • Problem-solving skills
  • Intermediate technical writing skills
  • Intermediate investigational writing skills
  • Basic knowledge of experimental design
  • Advanced knowledge of ERP, QSR, and GMP/GLP requirements
  • Advanced knowledge of industry/regulatory standards
 
Education:
BA or BS degree
 
Experience:
2-8 years of related experience
 
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
 
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
 

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