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Cmc Statistics Jobs in Hawaii (NOW HIRING)

Cmc Statistics information

What is a CMC statistician?

CMC Statistics professionals specialize in the application of statistical methods to Chemistry, Manufacturing, and Controls (CMC) activities within the pharmaceutical and biotechnology industries. Their work involves designing experiments, analyzing data, and ensuring product quality throughout the drug development and manufacturing process. They collaborate with scientists, engineers, and regulatory teams to support submissions to health authorities and maintain compliance with industry standards. By providing statistical expertise, CMC statisticians help optimize processes, validate analytical methods, and ensure consistency and safety of pharmaceutical products.

What are the key skills and qualifications needed to thrive as a CMC statistician?

To thrive as a CMC Statistician, you need a strong background in statistics, pharmaceutical sciences, and regulatory guidelines, typically supported by an advanced degree in statistics or a related field. Proficiency with statistical software such as SAS, R, and familiarity with quality systems and ICH/FDA guidelines is essential. Attention to detail, problem-solving skills, and strong communication abilities help you effectively analyze complex data and collaborate with cross-functional teams. These skills are crucial for ensuring product quality, regulatory compliance, and the successful development and manufacturing of pharmaceuticals.

What are some typical challenges faced by CMC statisticians, and how can they be addressed?

Professionals in CMC Statistics often encounter challenges such as managing large and complex datasets, ensuring data integrity across multiple stages of drug development, and effectively communicating statistical findings to multidisciplinary teams. Staying current with regulatory requirements and adapting to evolving analytical methods are also key challenges. These can be addressed by using robust data management systems, fostering strong cross-functional collaboration, and participating in ongoing professional development to stay updated with industry trends and regulatory guidance.

What is the difference between Cmc Statistics vs Data Analyst?

AspectCmc StatisticsData Analyst
Required CredentialsBachelor's in Statistics, Mathematics, or related field; often certifications in statistical softwareBachelor's in Data Science, Statistics, or related; sometimes certifications in data tools
Work EnvironmentResearch labs, pharmaceutical companies, or biotech firmsBusiness, finance, healthcare, or tech companies
Industry UsagePrimarily in pharmaceutical and biotech industries for clinical data analysisAcross various industries for interpreting data and supporting decision-making

While both roles involve data analysis, Cmc Statistics focuses on clinical and pharmaceutical data within biotech industries, requiring specialized knowledge of regulatory standards. Data Analysts work across diverse sectors, analyzing data to inform business strategies. Understanding these differences helps in choosing the right career path or job search focus.

What is a Cmc Statistics?

A Cmc Statistics role involves analyzing and interpreting data related to chemical, manufacturing, or clinical processes, often requiring knowledge of statistical methods and data analysis tools. Professionals in this field support quality control, process optimization, and regulatory compliance by providing accurate statistical insights.

Phlebotomist, PSC Float (DLS Oahu)

Diagnostic Laboratory Services, Inc.

Aiea, HI • On-site

$19.50 - $24.27/hr

Full-time

Re-posted 8 days ago


Job description

ABOUT DLS
Diagnostic Laboratory Services, Inc. (DLS) is Hawaii's largest locally owned and operated medical testing laboratory. DLS is considered a leader in the Hawaii, Guam and Saipan communities we serve. As an integral part of the patient care team, DLS uses state of the art testing and value-based informatics to promote optimal patient care and positively impact patient outcomes.
REGION
Town: Kuakini, Rehab, CMC, Liliha, St. Francis, Kalihi, Kaheka, Kapiolani
SCHEDULE
Regular Full-Time Position
Must be available Monday through Friday from 4:00 am to 8:30 pm, Saturday from 5:00 am to 1:00 pm and Sunday from 9:00 am to 1:00 pm.
Must be flexible with schedule changes to meet operational needs.
HIRING RANGE
Phlebotomist $19.50 to $24.27 hourly
Phlebotomist Certified $20.50 to $25.54 hourly
Actual pay commensurate with experience
Paid on-island training provided
Float position eligible for $3,600 annually (prorated for part time)
JOB SUMMARY
  1. Performs accurate patient identification, locates laboratory orders placed by authorized orderers, performs phlebotomy and other collections, processes and packs specimen for transport to the testing facility. May perform waived point of care testing and chain of custody toxicology collections. Patients are serviced with respect, compassion, and professionalism.

DUTIES AND RESPONSIBILITIES
1. Listed below are the major duties and responsibilities of this position. Essential job functions are identified with an
2. Performs collections from patients by venipuncture, finger sticks or other skin puncture techniques for routine, timed and stat orders. Procures or receives other non-blood specimens. (40-45%)*
a. Accurately identifies patients and collects specimens indicated in the orders
placed by authorized orderers.
b. Accurately labels specimens and verifies specimen integrity.
c. Organizes and cleans phlebotomy stations and/or phlebotomy collection bags.
d. Follows safety policies and procedures and pays special attention when disposing of contaminated sharps.
e. Nursing Homes: Performs phlebotomy at patients' residence.
3. Accessions laboratory test requests, including keying patient demographics into the Laboratory Information System (LIS). Performs accessioning of specimen orders. (40%)*
a. Obtains and/or verify pertinent patient information for laboratory testing and/or billing purposes.
b. Verifies information on requisitions for accuracy; obtains information as needed to ensure completeness.
c. Enters specimen information into Laboratory Information Systems (LIS).
d. Creates Test in Question (TIQs) that would affect testing. Resolves TIQs as applicable.
4. PSC, WCCHC and Guam/Saipan: Performs Non-Phlebotomy collections as required. (5%)
a. Performs urine drug collections (UDC).
b. Accurately identifies donor and completes chain of custody documents according to SOPs.
c. Performs observed collections.
d. Serves as a witness on behalf of DLS.
e. Performs breath alcohol testing (BAT).
f. Performs observed nasal, nasal, and/or nasopharyngeal collections.
g. Performs after hours collections at client or designated locations.
5. Prepares samples to be transported and/or shipped to Central or Reference Laboratory for testing. (10%)*
a. Ensures proper IATA process is completed as required.
b. Nursing Homes:
1. Processes order through the reference laboratory's electronic health record (HER) system.
2. Performs quality control (QC) on specimens before transport.
c. Guam/Saipan/Neighbor Islands: Pick up and drop off specimens from Patient Service Center to the main lab.
6. PSC, Guam/Saipan: Receives and processes invoices for laboratory services and submits accurate payment information to the Billing Department. (5%)
a. Reconciles cash/credit card payments daily.
b. Bank deposits as needed.
7. Nursing Homes: Assists client services as needed. (10%)
a. Contacts clients with critical laboratory results.
b. Performs client requests to add-on tests.
8. Performs other duties as assigned.
9. Job Expectations:
a. Demonstrates clear, audience-focused and effective communication with Aloha.
b. Reads, interprets and writes documents, such as policies, standard operating procedures and reports.
c. Creates a positive work culture and environment.
d. Models organizational values and contributes to quality improvements to support innovation.
e. Builds collaborative relationships with teammates: shares ideas, supports others to achieve goals and has each other's backs.
f. Follows all safety and health regulations and works in accordance with DLS safety policies and procedures to ensure a safe and secure working environment.
g. Provides excellent customer service to our internal and external customers with compassion and respect.
h. Maintains and values the importance of attendance at work.
i. Stays current on information and requirements to perform the job while embracing continuous learning to improve skills and knowledge.
j. Maintains a high level of confidentiality of information.
k. Uses sound judgement, analytical skills and innovation while problem solving and takes appropriate and timely actions.
l. Demonstrates flexibility and adaptability by adjusting to shifts in priorities, demands, and procedures.
JOB DEMANDS
Communication Demands:
  • Able to read and interpret documents such as safety policies and procedures, operating and maintenance instructions, and procedure manuals.
  • Able to produce detailed, accurate documentation for non-routine situations.
  • Able to effectively communicate information to internal and external customers in informal settings such as one-on-one and small group situations.

Typical Physical Demands:
  • Requires manual and finger dexterity, and eye-hand coordination, and corrected vision and hearing to normal range.
  • Able to wear personal protective equipment (PPE) such as, but not limited to, gloves, lab coats, face shields, and respiratory equipment.
  • Able to distinguish and identify colors.
  • Able to lift and carry supplies or equipment weighing up to thirty five (35) pounds occasionally.
  • Able to stand, sit, bend and key up to six (6) hours intermittently.
  • Able to perform require repetitive manual motion such as, but not limited to, pipetting, capping and uncapping specimens.
  • Depending on work location:
  • Able to walk up to six (6) hours frequently.
  • Able to drive and get in/out of company vehicle up to six (6) hours frequently.

Typical Working Conditions:
  • Work environment includes conditions common to a hospital/laboratory environment, including working directly with biohazardous materials, potentially hazardous chemicals and patients with communicable diseases. Potential for inadvertent skin, eye mucous membrane, or parenteral contact with blood or other potentially infectious materials possible.
  • Generally works in an indoor, air-conditioned area.

QUALIFICATIONS
Required:
  • High school diploma or equivalent.

Preferred:
  • Completion of a phlebotomy program.
  • Associates or Bachelor's degree in science.

Experience:
Preferred:
  • Phlebotomy, patient care or clinical laboratory experience.
  • Customer service experience.

Certification:
Preferred:
  • Certification as a Phlebotomy Technician by American Society for Clinical Pathology (ASCP), American Society of Phlebotomy Technicians (ASPT), (American Medical Technologist (AMT) or California State License (CPT I and CPT II).

Skills:
Required:
  • Ability to communicate effectively in English, both in verbal and written form.
  • Ability to work effectively both independently and with a team.
  • Excellent customer service skills.

Other Qualifications:
Required:
  • Nursing Homes and designated PSCs: If required to drive company vehicle, a valid driver's license and current traffic abstract.
  • Able to travel between business locations.

Equal Opportunity Employer/Disability/Vet