Careers

At LipoScience, we believe in making a difference in patients' lives, and we understand that our employees play a crucial role in achieving this mission. As part of our team, you will work with talented and dedicated colleagues with diversified experiences, strong ethics, and integrity while developing your career.

If you are interested in joining our team, please email your resume to recruiting@liposcience.com, or fax it to 919-212-1998. Please include the job title, job code, your salary requirements, and professional references. LipoScience offers a competitive compensation and benefits package. At this time, we are currently unable to accept resumes for positions that are not listed here.

Global Research Services: Manager, Global Research Services
Job Code: 300MGRS0712

LipoScience, a diagnostic company, is seeking to fill the position of Manager, Global Research Services

Responsibilities:

Project and Departmental management
Serves as primary contact person for all inquiries and study set-ups
Negotiates legal agreements, budget proposals as needed
Discusses specimen requirements, stability and transportation logistics with clients
Oversees each awarded study throughout its duration
Develops and maintains SOPs for department
Responsible for maintaining the document archive area.
Supervising daily responsibilities of staff members

Minimum Qualifications:

BS/BA Degree in a Physical or Biological Science
2-5 years of experience with clinical research trials
Experience in a clinical trial organization and/or laboratory is preferred

Knowledge and Skills:

Knowledge of clinical research regulations, laboratory processes and appropriate documentation
Strong attention to detail with organizational and project management skills
Ability to establish and maintain a positive rapport with clients
Ability to communicate verbally and in writing, at a high-level, in the English language
Ability to work independently with minimal supervision

Local Candidates Preferred.

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 300MGRS0712 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com. EOE

NMR Lab: Medical Technologist
Job Code: 411MT3711

LipoScience, a diagnostic company, is seeking to fill the position of Medical Technologist (1st shift, Sunday – Thursday).

Responsibilities:

Accurate and timely testing of specimens, operating and troubleshooting instruments, evaluating assay performance and resolving problems independently
Evaluating instruments, equipment, reagents, quality control, calibrator, and proficiency testing materials

Minimum Qualifications

Bachelor degree in medical technology, chemistry or other appropriate scientific discipline from an accredited college or university
Certification as a Medical Technologist by a CLIA approved certifying agency
Some experience as a Medical Technologist or Medical Technologist intern

Knowledge and Skills

Knowledge of clinical laboratory instrumentation, (including preventive maintenance, troubleshooting, validation), quality control and calibration procedures
Knowledge of quality control principles
Knowledge of evaluating quality control data, drawing appropriate conclusions as to the acceptability of such data
Knowledge of routine clinical laboratory testing procedures and ability to produce concise and accurate working protocols
Working knowledge of biological and chemical safety protocols, and laboratory safety rules
Knowledge of factors that can influence test results including a thorough understanding of the methodologies being utilized within the clinical laboratory
Knowledge of basic statistics a plus

Skills

Ability to organize and prioritize work
Ability to meet scheduled deadlines
Ability to work positively and professionally with employees
Ability to work across departments
MS Excel and MS Word skills
Ability to learn in–house software systems
Ability to learn NMR
Excellent trouble–shooting skills
Ability to work well independently
Ability to make sound decisions
Ability to read, comprehend and strictly follow all relevant safety procedures
Ability to appropriately complete compliance forms such as temperature, maintenance etc.
Ability to work effectively and efficiently under pressure, performing duties associated with the job
Ability to speak and write fluently in the English language

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 411MT3711 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com.

Operations and Human Resources: Human Resource Manager
Job Code: 901HRM0112

LipoScience, a diagnostic company, is seeking to fill the position of Human Resource Manager

Responsibilities:

The Human Resources Manager in conjunction with the Vice President of Operations leads human resource practices and objectives that will provide an employee-oriented, high performance work culture that emphasizes empowerment, accountability, quality and productivity, goal attainment and the recruitment and continuous development of a superior workforce.

Minimum Qualifications:

Bachelor Degree Required
7 - 10 years human resource generalist experience
3-5 minimum direct supervision of staff
Professional in Human Resource Certification (PHR required, SPHR preferred)
Demonstrated proficiency in laws/regulations
Hands on responsibility for full scope of HR initiatives (tactical and strategic)

Knowledge and Skills:

Knowledge of human resource laws and practices
Strong working knowledge of industry recognition, rewards practices including commercial organizations
Strong grounding in performance management and performance coaching processes
Ability to interface with diverse teams of individuals
Ability to utilize experience and judgment to plan and accomplish goals
Ability to be highly flexible and adaptable to fast paced and rapidly changing marketplace

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 901HRM0112 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com. EOE

Regulatory: Senior Regulatory Affairs Manager
Job Code: 529SRAM1811

LipoScience, Inc., a medical technology company, is seeking a Senior Regulatory Affairs Manager.

Responsibilities include:

Establish the appropriate submission strategy for the company's product development efforts
Preparation of regulatory submissions (IDE, 510(k), PMA)
Provide input on clinical study design and development of clinical protocols and support Quality System activities

Qualified candidates must possess a BA/BS, 5+ yrs of direct IVD industry experience in regulatory affairs and thorough knowledge and direct experience with the 510(k) and PMA submission process and FDA regulations.

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 529SRAM1811 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com.

Regulatory & Quality: Quality Assurance Specialist
Job Code: 525QAS0412

LipoScience, a diagnostic company, is seeking to fill the position of Quality Assurance Specialist to perform activities pertaining to assuring compliance with applicable regulatory requirements.

Responsibilities:

Assist with Manufacturing processes
Conducting internal audits-Internal Audit Team
Calibration and Equipment Maintenance
Documentation reviews and analysis
Help with batch records and laboratory data (e.g. QC data, screening data) and gives disposition (approval, rejection, etc.) to the lot or material produced to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released.
Performs audits of internal departments for compliance with FDA Quality Systems, cGMP regulations, CLIA, CAP, and Company policies and procedures.
Provides QA support during quality internal audits and regulatory inspections.
Reviews and approves of deviation investigations, out-of-specification investigations, atypical result investigations, etc. Actively participates in investigations and compliance related issues.
Review of document changes and change control relating to laboratory process and manufactured products.
Monitors and maintain control of equipment and equipment calibration program.
Informs management immediately if there are any significant quality issues. Prepares periodic written reports to update Management on the progress of the QA program.
Authors, reviews and edits documents, protocols, reports and Standard Operating Procedures (SOPs) as required.
Trains staff as necessary to ensure compliance with functional, cGMP, and corporate training requirements.
Knowledgeable in biopharmaceutical manufacturing, validation, Change Control, Validation, Critical Systems, and Major Equipment is preferred.
Work effectively with other departments and professionally communicates audit findings to contractors/vendors, management of other department and QA management.
Experienced with auditing, investigations, and working with contract services (manufacturing, laboratory, packaging, etc.).
Interact with FDA inspectors and other regulatory agencies.
Work independently and as part of a team.
Communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
Coordinate the flow of documents between QA and other departments.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.

Minimum Qualifications:

BS/BA with a degree in chemistry, biochemistry, microbiology or other related science and with 5 or more years experience in a medical device, IVD, and GMP regulated industry.
Experience with quality assurance responsibilities of medical device, IVD and laboratory operations and knowledge of cGMPs.
Experienced with auditing, investigations,, and working with contract services (manufacturing, laboratory, packaging, etc.).

Knowledge and Skills:

Knowledge in biotech manufacturing, Change Control processes, Critical Systems, and Major Equipment is preferred.
Skilled in Microsoft Office and database computer applications.
Must be able to coordinate the flow of documents between QA and other departments.
Must be able to interact with inspectors and other regulatory agencies.

Local Candidates Preferred.

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 525QAS0412 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com. EOE

Regulatory & Quality: Quality Engineer
Job Code: 525QE0512

LipoScience, a diagnostic company, is seeking to fill the position of Quality Engineer

Responsibilities:

Pre-production QA-Develops and maintains processes to support document and configuration control requirements,
Supports New Product Development and implementation / maintenance of Design Control processes.
Creation of quality plans that support the Medical Device and/or IVD company projects.
Responsible for Quality System records and documents within a regulated environment.
Maintenance, monitoring and improvement of quality system processes and procedures to ensure compliance, effectiveness and efficiencies consistent with organizational strategic goals.
Provide active support for consolidating and simplifying Quality Systems process to eliminate redundancy.
Identify and report opportunities for improvements and provide interactions with Production, Quality Assurance and other Departments to write procedures, protocols and records, and controlling and maintaining the engineering change control process.
Ensure the proper validation support to the organization.
Perform quality system assessments as needed and actively participates in internal quality system audits to include testing and visual inspections of products when applicable.
Participates in special projects and initiatives representing the Quality function as needed, including:
- Product/Project Core Teams
- Improvement initiatives regarding Quality, Cost, and Delivery
- Root Cause investigations and risk assessments
Support and assist validation and verification activities, including but not limited to protocol development and execution, deviation resolution, organize activities and create conduct retest when applicable.
Responsible for development of documentation methods to define QMS supporting tools. Responsible to create test protocols, coordinate execution, resolve deficiencies and assist with summary reporting activities.
Provides management, engineering, regulatory, and production with feedback on Quality issues.
Other duties as assigned.

Minimum Qualifications:

A minimum of ten (5-10) years experience in the medical device, IVD or BioTech industry, using a Quality System, process control, continuous improvement or other quality tools.
Bachelors degree in an appropriate technical discipline or equivalent work experience preferred in related area.
Demonstrated experience in the development and implementation of Quality System initiatives.
Strong verbal and written communication skills in order to effectively communicate with all levels of the organization
Experience, knowledge, and skill in the use of Microsoft Office software (Word, Excel, PowerPoint, Access, Visio).

Knowledge and Skills:

Knowledge of and previous training and experience with the established Quality System standards (i.e., QSR, MDD, CMDCAS, ISO, and/or cGMP quality systems)
Knowledge of quality metrics
Ability to multi-task and methodically manage multiple priorities and projects.
Team skills experience including actively participating or leading cross-functional teams.
Detail oriented with the ability to work independently -- must be a self-starter and highly motivated
Certifications in quality engineering, auditing, management or other ASQ program are desired

Local Candidates Preferred.

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 525QE0512 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com. EOE

Technology Service: Applications Specialist
Job Code: 528AS0312

LipoScience, a diagnostic company, is seeking to fill the position of Application Specialist.

Responsibilities:

Assist Customer in Qualification of systems and assays following installation
Develop and present product related technical information/data to a variety of audiences
Establish a good working relationship with each customer account in order to monitor customer satisfaction
Collaborate with corporate accounts, regional sales managers, technical support, and R&D in monitoring high profile accounts
Write, review, or edit technical service bulletins, service procedures, product manuals and updates
Develop training curricula

Minimum Qualifications:

ASCP certified as MT or MLT (MT preferred)
3ñ5 years of instrumentation, IVD, or NMR experience required
Valid drivers license and clean driving record required
Ability to travel

Knowledge and Skills:

3-5 years experience as applications specialist
3-5 years IVD Company experience
3-5 years customer training and problem diagnosis
Medical diagnostic instrument experience
Knowledge of NMR applications (preferred)
Knowledge of biological, chemical, and laboratory safety protocols and rules
Knowledge of routine quality control policies and procedures in a clinical laboratory

Local Candidates Preferred.

LipoScience offers an excellent benefits and compensation package. Please reference Job No. 528AS0312 when applying for this position. Please fax your resume, including references and salary requirements, to (919) 212-1998 (fax) or email recruiting@liposcience.com. EOE

Please consider joining the LipoScience team. Submit your resume to recruiting@liposcience.com.

EQUAL EMPLOYMENT OPPORTUNITY
LipoScience provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, national origin, age, sexual orientation, marital status, disability or military status and in accordance with applicable local, state and federal laws governing non-discrimination. This policy applies to all terms and conditions of employment, including but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.