Senior laboratory specialist job description

We are seeking a highly-skilled, professional technical manager to join our dynamic and growing team. In this position, you will oversee all technical matters associated with the biorepository. You will work collaboratively with eye banks, the development team, and various stakeholders within the project to ensure the characterization and processing of all samples in an efficient, timely manner.
Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

* Excellent medical, dental and vision coverage effective on your very first day
* 2:1 Match on retirement savings

Responsibilities*

* Work closely with the administrative project manager during all phases of the development lifecycle
* Work closely with Eyebanks for shipment and reception of samples
* Responsible for in-house characterization (OCT, fundus imaging and, histological characterization) of all donor tissues
* Responsible for preparing the tissues (dissection and processing) following standard operating procedures.
* Work closely with the administrative project manager and the UM central biorepository to maintain the sample inventory up to date.
* The technical biorepository manager will also work with the PI to advance and manage the in-house projects including multi-omics analysis.
* Report progress and provide insight and suggestions for improvement of the process.
* Contribute to study design and deliver results consistently and on time
* Ensure final sample and datasets produced meets expected quality

Required Qualifications*

* Bachelor's Degree in a recognized field of science or learning which is directly related to the duties of the position is required.
* 5-6 years of related experience, i.e., published in a field of specialty and academic knowledge in a field or discipline.
* Supervisory and financial management experience required.

Desired Qualifications*

* Master's or Doctoral Degree preferred.
* Evidence of experience in laboratory management
* Evidence of leadership skills and teamwork

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible

Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a diverse healthcare legacy that's served our community for more than 125 years. Put your skills to work with us, seek opportunities to learn and join a talented team where patient care is more than a job. It's our passion.
PRIMARY PURPOSE

Provides leadership to assigned employees for the processing of specimens, data entry, and troubleshooting to ensure the integrity of specimens and to expedite the completion of tests ordered.

MINIMUM SPECIFICATIONS

Education

* None

Experience

* Must have four years of laboratory support experience, including two years of Parkland laboratory experience.

Equivalent Education and/or Experience

* May have an equivalent combination of education and experience to substitute for the experience requirements.

Skills or Special Abilities

* Must be able to demonstrate leadership abilities.
* Must be proficient at operating a ten-key calculator.
* Must be able to enter 12-digit numbers into the computer without excessive errors.
* Must be able to communicate effectively with patients, visitors, and hospital staff.
* Must be able to follow written and oral instructions.
* Must have clear speech, normal hearing, and good visual acuity.
* Must be able to coordinate numerous telephone calls effectively.
* Must be able to handle detailed work and maintain a pleasant demeanor while under pressure.
* Must be able to use sound judgment when making decisions and solving problems.
* Must be able to exhibit good organizational skills and prioritizing abilities.
* Must be able to maintain accurate records/logs.

Responsibilities

1. Provides leadership by assisting the supervisor in selecting, training, motivating, supervising, and evaluating assigned staff to ensure maximum utilization and coverage of shift. Ensures that new employees are appropriately trained and competent in proper laboratory protocol and procedures and assures the documentation is complete.

2. Checks incoming samples and requisitions to determine sample integrity. Clarifies unclear test orders on downtime requisitions with patient care providers, in order to ensure proper patient care.

3. Orders/verifies requested test in Laboratory Information Systems computer and verifies sample receipt time. Label samples with bar code label to ensure that the two identifiers, patient name and medical record number, on the sample matches that on the bar code. 4. Prepares/processes specimens for testing/performance in the appropriate laboratory as required by that laboratory. Follows proper sample storage requirements. Delivers specimens to appropriate work area and other labs within established time limits as needed. Stocks supplies as needed.

5. Utilizes appropriate follow-up skills to interface with other Parkland internal and external customers on the telephone and in person to give out the appropriate information.

6. Assists with loading patient specimens on designated instrumentation and performs POC (Point of Care) testing as required.

7. Clocks in requisitions, separated by patient and triages by priority according to department protocol. Receives specimen deliveries by couriers, pneumatic tube system, or Parkland staff.

8. Performs special assignments such as teaching and orienting new employees, compiling statistics, researching errors, monitoring and ordering supplies and utilizing proper resources to verify patient account information. May function as a team leader as needed.

9. Maintains a clean working environment to ensure maximum safety for all employees.

10. Uses, monitors, and maintains assigned equipment according to lab protocol (ex: refrigerators, freezers, incubators, centrifuges, etc.)

11. Responsible for additional duties such as producing schedules, work aids and procedures. Helps to ensure routing of procedure updates and internal communication. Plans and organizes effectively and mobilizes and coordinates teams efforts.

Job Accountabilities

1. Identifies ways to improve work processes and improve customer satisfaction. Makes recommendations to supervisor, implements, and monitors results as appropriate in support of the overall goals of the department and Parkland.

2. Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.

3. Maintains knowledge of applicable rules, regulations, policies, laws and guidelines that impact the area. Develops effective internal controls designed to promote adherence with applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.

Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status.

Nearest Major Market: Dallas

Nearest Secondary Market: Fort Worth

Job Segment: Patient Care, Healthcare Administration, Data Entry, Healthcare, Administrative

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

This Senior Labs Compliance Specialist role represents the Rochester QC Laboratory on high complexity projects and project teams both within and outside of Quality Operations to include but not be limited to data integrity initiatives, PQS compliance requirements and continuous improvement projects.

The Sr. Labs Compliance Specialist will perform LIR investigations for Atypical results, OOS, Questionable, and Invalidated Data occurrences and will cover data integrity responsibilities for the lab.

This role provides leadership and technical expertise to assist the laboratory with instrument qualifications, method development (as needed), troubleshooting, investigations, computer validation.The Sr. Labs Compliance Specialist will be involved in second checking of data and will perform Laboratory testing as needed.

The Sr. Labs Compliance Specialist will be directly involved in implementation of system conversions (i.e. SAP, LIMS LITE), they may also assist with method improvements as well as other infrastructure support functions.

The Sr. Labs Compliance Specialist may defend QC Laboratory Quality Systems during audits and inspections.

How You Will Achieve It

•Leads and documents laboratory investigations for procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.

•Assures adherence to data integrity initiatives.

•As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems.

•Determines scheduling priorities and workload distribution to ensure customer needs are met with minimal guidance from QO Lab leadership.

•Proactively identifies opportunities for improvements to procedures/processes and actively drives those improvements.

•Manages the balance of daily workload and customer priorities within the team with minimal guidance from QO Leadership.

•Performs 2nd check of laboratory data packets

•Performs analytical assays and microbiological testing (i.e., sterility, LAL, Water testing, Growth promotion).

•Partner with validation and completes lab related instrument qualifications.

Demonstrates a technical mastery of chromatography.

•Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.

•Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.

•Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR bachelors with at least 3 years of experience OR master with more than 1 year of experience.
• Prior experience with instrument qualification, SOP revisions.
• Ability to receive feedback and takes accountability for actions and personal development
• Excellent effective written and verbal communication and interpersonal skills
• Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Nice-to-Have

• Laboratory and Quality Investigation experience
• Chemistry Laboratory experience, including HPLC
• Experience in investigating and documenting out of specification laboratory results.

Work Location Assignment:On-Premise

PHYSICAL/MENTAL REQUIREMENTS

Must NOT be allergic to Penicillin.

Laboratory and office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg. Must have the ability to maintain mental focus on multiple complex challenges throughout a shift.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

There is no routine travel.Normal work hours are Monday - Friday 0800 a.m. - 04:30pm. Work outside of core work hours / weekdays will occasionally be required to support projects, investigations, etc. as defined by business need.

Additional Information

• No relocation support available.

Last Date to Apply for Job: October 7, 2022

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

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