Careers – Ipsum Diagnostics

CAREERS

Ipsum Diagnostics is dedicated to providing exceptional services to the clients we serve. Talented, motivated and passionate individuals will be empowered and supported on their career path.

Benefits:
Ipsum Diagnostics supports employees by offering a comprehensive benefits package including fully paid health, vision and dental insurance, disability insurance, life, and AD&D insurance, PTO, holidays, and employee assistance programs with 24/7 resources and support to assist with professional and personal matters.

OPEN POSITIONS

Molecular Lab Quality Control Specialist

Support Quality Assurance and Control operations, scheduling, maintaining workflow, assuring tasks to be done on time, test records are initiated and reviewed on a timely manner. Previous experience working with CAP peer-based laboratory accreditation program. Supports Quality Assurance (QA) Manager activities.

Ensure laboratory operations and test results are meeting and exceeding industry standards for clinical laboratory testing for diagnostic purposes. Provide test results to management and update reporting sheets to be accessible.

Implement standards, methods and procedures to inspect, test and evaluate accuracy and reliability of in compliance with regulatory statutes executed with a high level of excellence; effectively analyze and communicate Quality data and metrics to upper management; monitor and maintain Quality Control (QC) on facility and equipment.

Direct QC testing on in-process, testing, stability and/or research samples. This involves, but not limited to, testing documentation, and calibration of equipment.
Execute validation protocols for new and existing equipment and methods; conduct data management and analysis.
Identify continuous process improvement areas, in compliance with clinical testing processes and documentation for QC activities with a high degree of accuracy and efficiency.
Work with QC Manager to implement and evaluate operational changes to improve productivity and the quality and efficiency of laboratory services.
Work with QC Manger to oversee QC operations, including lab and equipment cleaning and qualification, minor equipment maintenance, maintaining and managing lab materials (e.g. supplies), completion of documentation (e.g. equipment logbooks, inventory forms); maintain laboratory supplies through ordering and preparation of reagents, laboratory organization
If QC Manager requests, may perform internal audits and risk assessments
Author new SOPs, review and revise established SOPs, related to quality control testing and operations.
This may also include developing and optimizing assays, conducting limited literature search of research study protocols and reports, regulatory documents, and other potential resources

Excellent project management, time management, and multi-tasking skills

Excellent written and verbal communication skills
Excellent computer skills with knowledge of spreadsheet, word processing and statistical analysis software
Ability to manage competing priorities or projects
Ability to function independently, exercise good judgement and work in a team-based environment

Ability to identify problems and solutions then act to resolve

Demonstrated ability to resolve operational and strategic issues
Ability to understand instructions and to learn how to maintain equipment
Ability to apply attention to detail as applied to data review and compliance
High degree of reliability and professionalism
Ability to analyze and report results
Perform other duties as assigned
Monitors advance maintenance and troubleshooting of equipment and instruments.
Coordinates correction of malfunctions with service representative.
Reviews accuracy and timeliness of patient test results; provides data for and prepares operational and statistical reports for management and regulatory agencies to comply with regulations.
Works with QC Manager to prepare laboratory for inspection or accreditation visits including staff compliance with policies and procedures and proficiency testing program.
Monitors research and development activities within the laboratory; assists in the development and implementation of new procedures.
Performs high complexity laboratory tests as required.

Qualifications:

Bachelor’s degree from accredited institution in life science, biology or related field. Advanced Degree, preferred, ASCP preferred
Minimum of seven (7) years of related professional experience in laboratory setting, with at least four (4) years of QC role
Minimum of two (2) years direct supervisory experience
Experience in Molecular Biology, required
Knowledge of quality systems and regulatory requirements.
Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
Excellent problem-solving and analytical skills applied to investigations

This position will have supervisory responsibilities.

This position reports to the Quality Assurance Manager, Molecular Manager and Molecular Director.

Molecular Laboratory QA Manager Job Description

A laboratory quality manager ensures that the data results from the lab are accurate. They must run a lab that follows safety and quality assurance procedures, seeing to it that employees are properly trained and always complying with necessary rules and regulations. This highly trained professional works hard, well organized and can be counted on.

Skill Set

A combination of analytical, communication and reasoning skills to accurately and efficiently run a lab is a must. Laboratory Quality Managers must be able to read and write policies regarding safety and quality assurance procedures for use in the lab. Laboratory manuals are often thick with industry words, phrases and diagrams, so a good Quality Manager can read and interpret these documents with ease.

Primary Responsibilities

As the person in charge of ensuring results of the highest quality, the Quality Lab Manager creates systems to monitor data quality and performance. A Quality Manager also confirms that procedures adhere to safety and compliance rules and regulations.

The Quality Manager’s job to ensure testing is conducted in the timely manner. The Quality Manager also participates in hiring and manages staff, ensuring that all employees receive proper training. The Quality Manager may also work with vendors, also verifying whether they follow the lab’s standards.

Duties include:

Identify continuous process improvement areas, in compliance with clinical testing processes and documentation for QC activities with a high degree of accuracy and efficiency.
Implements and evaluates operational changes to improve productivity and the quality and efficiency of laboratory services.
Supervise QC operations, including lab and equipment cleaning and qualification, minor equipment maintenance, maintaining and managing lab materials (e.g., supplies), completion of documentation (e.g., equipment logbooks, inventory forms); maintain laboratory supplies through ordering and preparation of reagents, laboratory organization
May perform internal audits and risk assessments
Review and revise established SOPs, related to quality control testing and operations.
Select, develop, evaluate, (PT) and supervise personnel to ensure efficient operation of Quality Control Qualifications:

Secondary Tasks

Laboratory Quality Managers often work collaboratively with customer service who respond to inquiries with unsatisfied customers. QM will review data discrepancies to see if an error was made and explaining any resulting corrective procedures. Quality manager keeps up with industry trends by
reading current publications, maintaining memberships in professional organizations and may even attend industry conferences. The Quality Manager may also serve as the company representative during all lab audits, assisting auditors with any inquiries and reporting findings to management.

Duties include:

Reporting of inconsistencies, malfunctions or variations from prototype
Written explanations of flaws
Procedural evaluation
Recommendation of new or revised methods for production efficiency
Ensure site compliance with applicable regulations such as CLIA, FDA etc., and monitors regulatory trends and development.
Oversees the quality control (QC) program and develops new QC and data review procedures.
Manages document control systems and SOP periodic review process, authors policy-level documents such as site quality manual, risk management manual.
Oversee deviation program, out of specification/out of trend (OOS/OOT) investigations, corrective and preventive actions (CAPA) program, and provide guidance for investigations and corrective actions.
Review QC trending reports from the QC Scientist and provide guidance for investigations and corrective actions when needed.
Work with surveillance director and manager to design trending metric and perform data analysis when necessary.
Develop quality metrics and key performance indicators and present quality metrics at quarterly management review meetings.
Author, review, approve validation documents, maintain QC binders ensure they are complete.
Authors QC reports for client studies, as needed, maintains PT files on employees.
Design, monitor and review internal audits of studies and/or systems to assure integrity. Provide audit reports to senior management and/or study directors.
Familiar with Media Lab or similar document control and management programs.

Education and Certifications

A laboratory quality manager must have a bachelor’s degree, preferably in a science or quality
management specialty.

Requires a Bachelor’s Degree in Clinical Lab Sciences or a related science field from an accredited college or university, and at least 5 years laboratory experience, preferably in a quality control/quality assurance role in a regulated clinical environment, or a Master’s degree in one of the clinical laboratory science fields from an accredited college or university and at least 2 years laboratory experience, preferably in a quality control/quality assurance role in a regulated clinical environment.
Prior experience in demonstrated audit responsibilities, including interactions with regulatory agencies such as the FDA, and responding to documented observations as needed.
General understanding of applicable industry regulations and guidance documents and their application to quality within the laboratory.
At least 5 years of supervisory or management experience, and reasonable knowledge of fiscal management is required.
Demonstrated proficiency in communication fosters positive working relationships amongst staff.
Strong attention to detail and exceptional follow-up skills.
Strong initiative, sense of urgency, and commitment.
Solid organizational and project management skills with the capacity to prioritize and multi-task.

Background and experience should include attributes from the following concepts and models:

Quality Control Fundamentals
Reliability Concepts
Quality Circles
Statistical Quality Control
Instruments and Tools
Thorough knowledge of quality systems and regulatory requirements

This position reports to Laboratory Director and works directly with Molecular Lab’s Quality Assurance and Control Specialist.

Talent Acquisition Specialist

Ipsum Diagnostics is looking to add to our Human Resource Department. If you are a dynamic individual with a passion for service excellence and would like to be an integral part of our success, please consider joining us at Ipsum.

Summary:

The Talent Acquisition Specialist will be responsible for Full life-cycle recruitment across all levels and accordance to employment laws and guidelines. The expectation will be for you to successfully manage and close candidate searches against a timeline. The Talent Acquisition Specialist will have extensive knowledge of Talent Acquisition and experience forging collaborative and credibility-based relationships with business leaders, Human Resources, hiring manager.

The Talent Acquisition Partner must be able to identify resolution to issues and take actions, be able to work in a fast-paced environment. The ideal candidate for this position will have some previous experience in strong organizational, administrative and communication skills as well as the ability to prioritize and set goals.

Responsibilities:

Build relationships with hiring managers, Operations managers, HR to understand current line of business needs and objectives. Define job descriptions and develop and implement recruiting strategies that fit business needs and budget considerations through a deep understanding of return on investment.

• Identify and implement appropriate recruiting processes such as setting clear expectations for deliverables with hiring managers, discussing candidate assessments, and closing approaches, coaching interview team on selective/behavioral interview techniques, etc.
• Successfully review job descriptions to understand the needs of hiring managers as well as ask relevant questions that will help identify the right candidate(s). Effectively market each position that you are hiring for.
• Diligently pursue a broad and deep understanding of all aspects of the business lines you support, including core competencies/skill sets, and our company. Leverage your understanding of the marketplace to assist hiring managers set realistic expectations of candidate skill sets, experience, and the all-around competitive landscape.
• Identify top level talent through aggressive sourcing methods which include internet research, networking, direct sourcing, employee referrals, advertisements, associations, and other sources as needed. Research and recommend new sources for active and passive candidate recruiting. Develop a pool of qualified candidates in advance of need.
• Conduct screening and selection interviews that follow company guidelines, meet legal requirements, and gather job appropriate candidate information.
• Communicate regularly with hiring managers to establish rapport, provide status updates, and determine the effectiveness of recruiting plans and implementation. Collect, analyze, and distribute feedback to candidates, and hiring managers throughout the recruitment process.
• Share knowledge and identify opportunities for candidates (internal and external) to assist them in their professional development. Motivate candidates and provide appropriate direction and advice that may impact career decisions.

Minimum Qualifications

• Experience recruiting professional level hires either on the agency or corporate in-house environments.
• 3-5+ Years of Expert knowledge of full lifecycle recruitment, including thorough pre- qualification screening, interviewing, and closing professional level candidates across multiple levels.
• Experience forging collaborative and credibility-based relationships with business leaders, hiring managers and HR business partners.
• Demonstrated expertise in sourcing, recruiting, and placing talent from a multi-source pipeline including internal candidates, internet/multimedia souring, networking, direct application, and other methodologies.
• Strong business acumen required.
• Experience managing and prioritizing multiple searches, projects, and client relationships.
• Performs other duties as assigned.

Molecular Technologist
(FULL time)

This person will be responsible for performing Molecular diagnostic assays according to established standard operating procedures. They will be responsible for executing clinical laboratory protocols, including but not limited to: Nucleic acid extraction, PCR, qRT-PCR, etc. and result analysis and reporting.

AVAILABLE SHIFTS

Tues-Sat 7am-3:30PM (Full Time) First Shift
Tues.-Sat 3pm-11pm (Full Time) Second Shift
Tues-Sat. 11pm-7am (Full Time) Third Shift
Sun-Thurs. 11pm-7am (Full Time) Third Shift

This position reports to the Molecular Diagnostics Supervisor

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Preparation of samples for analyses on the QuantStudio 12K Flex Real-time PCR System
• Preparation reagents, standards, and controls as required
• Proper use of all specimen handling protocols and thorough and accurate performance of molecular diagnostics assays according to laboratory guidelines
• Follows laboratory procedures as documented in the Standard Operating Procedures Manual for the assigned laboratory section
• Assists with inventory; QC and Preventative Maintenance (PM) documentation
• Assures the accuracy of all tests performed by adhering to the laboratory’s Quality Control Program
• Participates in performing routine equipment maintenance and function checks
• Analyzes and records test data to issue technical reports or prepare graphs and charts to document experimental results
• Independently performs laboratory testing through professional knowledge of laboratory procedures, execution, interpretation and/or analysis, in an accurate and timely manner.
• Responsible for QC & daily maintenance
• Performs other duties as assigned. Utilizes spare time to seek out and complete extra tasks.

REQUIREMENTS:
• 2 years Molecular Laboratory experience (Preferred)
• Bachelor’s Degree in Science, CERTIFICATIONS: Molecular Technologist MB (ASCP)
• Strong interpersonal and communication skills needed for interaction with all members of laboratory team
• Experience in a Molecular lab setting using biosafety cabinet and utilizing aseptic technique
• Experience with automated instrumentation (in particular the QuantStudio 12K Flex)
• Knowledgeable in a variety of programs, including MS Office, and familiarity with LIMS systems
• Strong written communication skills
• Ability to multi-task, and work under pressure
• Night shift work required

Molecular Supervisor
(Mon-Fri) 7am-3:30pm

As the world is experiencing an unprecedented pandemic, there is an urgent need for additional laboratory testing facilities to process and test for the COVID-19 virus here in the United States. To that end, Ipsum Diagnostics is actively providing quality laboratory testing at our facility.

Summary:
We are currently recruiting Licensed Laboratory Supervisor/Molecular Supervisor experienced in Pipetting, PCR, and DNA/RNA Extraction for immediate hire. In this role, the Lab Supervisor will be responsible for overseeing all lab functions, quality control, assisting with test samples as well as entering, reviewing and reporting test results.

Responsibilities:

• Adhere to and follow laboratory established procedures for processing, analyzing, and reporting patient samples.
• Follow laboratory established quality control policies and protocols in recording readings, note deviations and document all corrective actions taken when deviations occur.
• Be capable of identifying problems that may affect test performance and turnaround time and immediately bring it to supervisor, Director, or Medical directors’ attention.
• Be proficient in a wide range of routine and complex assays performed at Ipsum with appropriate training.
• Be willing to run automated Nucleic Acid instrumentation, real time PCR, DNA/RNA spectrometer, genetic scanners, and other instruments with appropriate training.
• Assist in performing proficiency testing as required.
• Assist in improving quality management and writing/updating SOPs as required.
• Organize and analysis data and help troubleshoot issues with supervisor.
• Understand and follow OSHA, CLIA* and CAP guidelines.
• Plays a key role in maintaining instrumentation and the appropriate documentation for each instrument and assays in their department.
• Demonstrate a high level of ethics in all aspects of professional practice.
• Ensure the accuracy of the information before filing and reported.
• Maintain a clean, safe, and organized lab.

Skills and specifications for this position:
• BS in biological science or equivalent with at least one year of training/experience
• MB (ASCP) Certification Current
• Laboratory personnel participating in licensure or certification maintenance programs must complete the number of continuing education courses prescribed by the licensing or certifying agency.
• Technical laboratory personnel whose certification has been grandfathered and does not require participation in a certification maintenance program must complete at least twelve hours of continuing education annually.
• Lab experience and/or training in a clinical laboratory setting. Required experience in clinical molecular diagnostics for 3 to 5 years.
• Must satisfy requirements for high complexity testing under CLIA regulations (42 CFR, part 493).
• Excellent analytical abilities and communication skills (verbal and written).
• Excellent practical knowledge about the applications of scientific principles.
• Detail-oriented with the ability to spot mistakes in procedures and correct them.
• Ability to work well in a group as well as carry out individual assignments.
• Proficient in computer and internet application skills required for the job.
• Ability to escalate issues appropriately
• Ability to focus for long periods on a task, detailed-oriented and able to lift 50lbs, and willingness to learn.
• Prior supervisory experience is preferred.

Safety:
• Adherence to standard universal precautions.
• Exposure to biological and chemical hazards.

Molecular Supervisor
(Tuesday-Saturday11pm-7am) “NIGHT SHIFT”

Responsibilities:

Safety:
• Adherence to standard universal precautions.
• Exposure to biological and chemical hazards.

Ipsum Diagnostics LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.