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Manufacturing Engineering Lead

Lead Innovation in Manufacturing Excellence

About CBG Biotech

CBG Biotech is a leading innovator in the design and manufacture of advanced solvent recycling equipment at our Solon, Ohio facility. Founded with a purpose to make the world a cleaner place through sustainable practices, we help laboratories, universities, and industrial organizations reduce their carbon footprint through sustainable resource recovery. Since 1995, we’ve partnered with leading institutions to improve efficiency, minimize waste and advance environmental responsibility. As we expand our product portfolio, we’re looking for passionate professionals to join our growing team and drive innovation forward. Learn more at Summary

We’re seeking a Manufacturing Engineering Lead who thrives in a dynamic environment and wants to make a real impact. This role blends hands-on technical expertise with operational leadership, giving you the opportunity to design and implement improved manufacturing methods, optimize processes and drive efficiency, quality, and safety. You’ll collaborate with cross-functional teams to enhance product design, support new product introductions, troubleshoot technical issues and lead continuous improvement initiatives—all while contributing to long-term operational strategies that align with company goals. Leveraging your proven expertise, this is a chance to become a foundational leader at a fast-growing company with unlimited potential.

Key Responsibilities

• Lead manufacturing engineering activities: process design, optimization, and troubleshooting.
• Develop and implement operational procedures and SOPs for scalability and compliance.
• Manage operations of Production Department ensuring unit builds meet design, quality and delivery requirements.
• Collaborate with cross-functional teams to align design, engineering, manufacturing, quality and supply chain strategies.
• Drive continuous improvement initiatives using Lean/Six Sigma principles.
• Manage implementation of Engineering Change Orders, process documentation, and revisions to ERP system to support CBG’s processes and operations.
• Formulate and execute test strategies/methods for product testing and validation.
• Lead and develop a high-performing production team.
• Support strategic initiatives and advancement of corporate goals.
• Perform other related duties as assigned by the Engineering Manager or Executive Leadership.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering or a related discipline (Master’s degree a plus).
• Minimum 5 years of hands-on experience in manufacturing environments; 8 years preferred.
• Strong problem solving skills and a proactive, results driven mindset.
• Experience with lean manufacturing principles, Six Sigma and continuous improvement methodologies
• Skilled in developing test methods, validation protocols, and performing root cause analysis.
• Proficiency in CAD software and ERP systems.
• Strong communication, organizational and time-management skills
• Proven ability to lead operations and drive results.

CBG Biotech offers competitive salary, Paid Time Off, Life/Medical/Dental/Vision/Disability insurances and 401K match. Flexible work week: 9 hour workday M-Th + 4 hour workday on Friday!

All candidates must pass drug and background screening.

Manufacturing Engineer – Advanced Detector Systems

Location: Sturbridge, MA (100% Onsite)

Salary: Up to $140K depending on experience

Environment: ISO 7 Cleanroom, High‑Voltage/High‑Vacuum Equipment

Candidates with backgrounds in semiconductor fabrication, vacuum systems, photonics, electron‑optical components, or high‑voltage instrumentation are strongly encouraged to apply.

Position Summary

We are seeking a hands‑on Manufacturing Engineer to support electrical testing, troubleshooting, and production of advanced detector technologies, including microchannel‑based devices and electron‑multiplying components. This role is highly technical and hardware‑focused, requiring daily work on the production floor within an ISO 7 cleanroom.

You will ensure detector assemblies meet stringent electrical, vacuum, and performance specifications while supporting test station operations, conducting full detector teardowns, and maintaining test capability during high‑priority manufacturing periods. This position also plays a key role in transitioning from manual testing to more automated systems.

What You’ll Do

Electrical Testing & Data Integrity

• Perform electrical testing on detector components using high‑vacuum systems (10⁻⁷ to 10⁻⁶ Torr).
• Maintain test stations and ensure data accuracy and traceability.
• Identify and escalate anomalies in test results.

Troubleshooting & Failure Analysis

• Diagnose electrical, mechanical, and vacuum‑related issues in detector assemblies.
• Conduct full mechanical and electrical teardowns.
• Investigate failure modes such as low gain, shorts, contamination, vacuum leaks, alignment issues, or component damage.

Manufacturing Support

• Work directly with cleanroom operators to resolve production issues quickly.
• Update work instructions, procedures, and test documentation.
• Train operators and new engineers on testing, teardown, and handling methods.
• Support yield improvement and scrap‑reduction initiatives.
• Track, analyze, and report yields, scrap rates, and defect trends.
• Provide day‑to‑day support across multiple product lines; occasional off‑shift work may be required.

Process Control & Continuous Improvement

• Use MINITAB for basic SPC, trend analysis, and yield monitoring.
• Support the transition from manual to semi‑automated test equipment.
• Identify opportunities to improve test repeatability, throughput, and data capture.
• Contribute to Lean Manufacturing, 5S, and SPC implementation.
• Promote adherence to ISO 9001‑based quality systems.

Equipment & Fixture Support

• Maintain and configure high‑voltage power supplies, vacuum controllers, electrometers, oscilloscopes, and custom fixtures.
• Assist in modifying fixtures or creating temporary setups to maintain production continuity.

Required Qualifications

• U.S. citizenship (required due to ITAR regulations).
• Bachelor’s degree in Engineering (Electrical, Mechanical, Materials, Physics, or related field).
• Hands‑on experience with high‑voltage systems, high‑vacuum equipment, precision instrumentation, or cleanroom operations.
• Strong mechanical aptitude and comfort working directly with hardware.
• Ability to troubleshoot electrical and mechanical issues methodically.
• Strong technical communication skills—written and verbal.
• Proficiency with MS Office, MRP systems, databases, and analytical/statistical tools.
• Ability to work full‑time onsite in an ISO 7 cleanroom environment.
• Willingness to learn specialized detector physics and test methods.

Preferred Qualifications

• Background in semiconductor, photonics, vacuum systems, electron optics, or detector technologies.
• Experience with SPC tools, MINITAB, or basic statistical analysis.
• Familiarity with high‑voltage power supplies, vacuum chambers, turbopumps, or electrometers.
• Experience assembling or disassembling delicate electro‑mechanical components.
• Understanding of gain behavior or noise mechanisms in electron‑multiplying devices (e.g., PMTs, MCPs, avalanche detectors).

Work Environment

• 100% onsite in a high‑tech manufacturing facility.
• ISO 7 cleanroom requiring gowning, gloves, and contamination‑control procedures.
• Work involves high‑voltage and high‑vacuum equipment; full safety training provided.
• Standard day shift with occasional support needed for urgent production issues.
• PPE such as safety glasses, gloves, and hearing protection may be required.

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Title:- Quality Control Analyst I

Location: Swiftwater, PA

Duration: Contract until Dec 2026 (Possible extension)

Position Overview

Mon-Fri or Tues-Sat (8-4:30EST)

This position requires the individual to perform routine testing as scheduled to support production, method validation as well as the stability program, and completing the required documentation.This position is fully onsite with 0-3 years, entry position with lab experience, agarose gel work, pipetting, LIMS, excel, etc. Candidate will need to work well in a faced pace lan with critical thinking and group setting.

1st Shift: Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provide an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aid in the development of test methods. Conduct data review and preliminary evaluation of results. Solve problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provide input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contribute to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.. Years of Experience: 0 - 3 Years

Thanks

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

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Job Overview

We are seeking a team member to join the Hardware Manufacturing team. In this role, you will align, calibrate, and execute test methods of varying complexity based on operational plans and production demand. This position is ideal for individuals who thrive in a team-oriented, goal-focused environment and can follow structured processes to meet daily, monthly, and quarterly objectives.

Key Responsibilities

• Align, calibrate, and execute test methods as per operational requirements
• Follow established operating procedures and maintain accurate training records
• Ensure smooth material flow and timely completion of work orders
• Read, understand, and follow work instructions with a strong focus on quality
• Execute daily production plans while meeting quality and timeline expectations
• Follow engineering drawings, SOPs, and work order specifications during manufacturing
• Perform assembly tasks under supervision following standard procedures
• Troubleshoot issues and escalate when necessary
• Ensure compliance with quality and regulatory standards (QSR, GMP, ISO)
• Collaborate with cross-functional teams to resolve issues and maintain quality standards
• Identify and recommend improvements in production methods, equipment performance, and efficiency
• Participate in lean manufacturing initiatives
• Maintain a safe and clean work environment
• Train new team members on processes and equipment as needed
• Complete required documentation and maintain accurate production records

Qualifications

• Ability to read, write, and speak fluent English
• Proficiency in Microsoft Office applications
• Strong decision-making and prioritization skills
• Ability to work effectively in a team-oriented environment

Plant Manager

CentroMotion | Weasler Engineering

West Bend, WI

Welcome to CentroMotion, a global leader in manufacturing friction products, information and control devices, mechanical power transmission products, and thermal and motion controls. Our solutions are used in transportation, agriculture, construction, mining and industrial environments, and are designed to meet the unique needs of OEMs and aftermarket networks.

At CentroMotion, we pride ourselves on deep subject matter expertise, long-term partnerships, and a drive for innovation and continuous improvement to help our customers achieve their goals. Our brands, including Carlisle Brake & Friction, CrossControl, Elliott Mfg., Gits Mfg., maximatecc, Power-Packer and Weasler Engineering, are recognized for their quality and reliability.

Join us and be part of a team dedicated to helping build, move and feed the world.

Your Role: The Plant Manager for our Weasler Engineering-West Bend WI, will be responsible for executing company objectives, accelerating operational achievement of standard for manufacturing and operational capabilities. This position will also champion and lead the Continuous Improvement efforts.

What You'll Be Doing

• Develop world class operational standards of measuring and achieving key performance goals to meet manufacturing requirements achieving customer satisfaction on time and within budget i.e. On Time Delivery, Scrap Reduction, Quality, Safety, Cost Control, Waste Reduction, capacity planning, inventory, production scheduling, and performance measures.
• Drive Standard Work to all manufacturing processes through Kaizen events and involve employees at ALL levels.
• Develop and improve manufacturing processes for greater efficiencies, i.e. work instructions, process flow, material usage, and material flow, cross training, visual performance (productivity-throughput, quality, OTD) and goals.
• Lead the development and expansion of continuous improvement methodologies in Medina to establish and improve manufacturing processes for greater efficiencies and gain positive results in materials usage, shipping and receiving, capacity planning, inventory, scrap reduction, production scheduling, safety, quality, customer satisfaction, and performance measures.
• Work with Staff Management within the business unit to develop and execute the strategy/plan and to identify the needs of the company regarding the PCIS process.
• Responsible for the quality improvement and cost reduction of assigned products. Responsible for meeting plant cost reduction goal for four wall and material costs.
• Provide leadership for problem resolution and use formalized problem solving approaches (A3, FMEA) to effectively define problems and drive to solutions.
• Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues (e.g. six sigma methodologies, and other related problem solving processes).
• Responsible for materials management including purchasing, planning, and inventory control.
• Support and ensure ISO 9000 processes and procedures are developed and implemented and coordinates preventative measures to enhance system capability.
• Reviews new product designs for effective and low cost method of manufacturing. Initiatives action and follow-up to incorporate changes prior to pre-production sign off.
• Specifies and/or provides necessary tools, fixtures, equipment and related training as required for plan production and testing. Follows up to ensure efficient ergonomic safe operating conditions and methods.
• Responsible for administrating major capital investments and improving cost structure of manufacturing operations and facilities.
• Builds, develops and manages operations leadership team capable of carrying out needed operations strategies and improving employee relations.
• Maintain and nurture effective working relationships/communications with key support functions to improve and ensure effective support and achieve business goals and objectives.
• Responsible for Safety and Environmental policies and adherence.
• Performs other duties as assigned.

What Will Set You Apart

• Bachelor’s degree in Technical/Industrial Engineering. MBA is a plus.
• Demonstrated proven ability to lead people and get results through others.
• Solid commitment to Set-Manage-Deliver.
• Extensive experience with problem analysis and resolution at both strategic and functional levels.
• Passion for root cause analysis and methodical problem solving.
• Union experience a plus.
• Technical skills in lean/six sigma manufacturing techniques in all aspects of plant operations.
• Excellent communication and facilitation skills – both oral and written, demonstrated by the ability to effectively present information and respond to questions from groups of managers, customers, peers, and production floor community.
• Solid experience in a vertically integrated manufacturing environment involving stamping, extrusion and critical high volume to low volume assembly.
• Technology/Equipment: Strong proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).

What We Offer

• Comprehensive Health Benefits: Enjoy medical, dental, and vision coverage for positions of 30+ hours/week.
• Health Savings Account: Benefit from annual employer contributions to your HSA.
• Company-Provided Insurance: We offer life insurance, accidental death and dismemberment coverage, and short-term disability insurance.
• Voluntary Insurance Options: Choose additional coverage for yourself, your spouse, and your children, including critical illness, accident, hospital indemnity, and long-term disability insurance.
• 401(k) Plan: Take advantage of our 401(k) with matching contributions, fully vested from day one.
• Educational Support: Access tuition reimbursement and scholarship opportunities to further your education.
• Lifestyle Reimbursement: Receive a $150 Amazon gift card upon completion of your annual physical.
• Wellness Program: Participate in health coaching, monthly webinars, quarterly challenges, and earn gift card incentives for participation and earning points.
• Safe Work Environment: Work in a clean and safe environment.
• Generous Paid Time Off: Enjoy 14 paid holidays, including a holiday shutdown between Christmas and New Year’s, plus paid vacation available from day one.
• Paid Parental Leave: Take advantage of paid parental leave to support your family.

Job Title : Research Associate ( Associate Researcher )

Location : South San Francisco - 94080

Duration : 06 Months

Job Description :

• Direct, hands-on experience with adeno-associated viral nanoparticles
• Successful experience operating electrophoresis (CE, SDS-PAGE, alkaline gel, etc.), light scattering (DLS, MALS, etc.), UV/Vis spectrophotometry, or other technologies for protein/DNA-based product development.
• Experience operating PCR methods.
• Experience in analytical method development and assay transfer.

Experience operating chromatography methods (HPLC, etc.) and proficient understanding of chromatography software.

Position Title: QC Chemistry Lab Technician

Duration: 6 Month Contract (possibility of extension & conversion)

Schedule: Night Shift, 2-2-3 Schedule (6 pm – 6 am)

Location: Durham, NC

Position Summary

The Chemistry Lab Technician is responsible for performing accurate, timely testing of routine and stability

samples in alignment with GMP and safety guidelines to support site production and stability programs. This role

ensures compliance with site policies and procedures while conducting laboratory analyses using techniques such

as UV-VIS, TOC, pH, Conductivity, Color, Clarity, Osmolality, and Visual/Functional Inspection. The technician

may also review testing results and conduct second-person witnessing as needed.

Key Responsibilities

• Perform analytical test methods and support activities safely and accurately following established

procedures and protocols.

• Record data in reports or LIMS according to laboratory procedures, standards, and GMP requirements.

• Identify deviations from procedures or methods and initiate investigations when required.

• Review analytical data generated by other lab analysts as needed.

• Adhere to all Environmental, Health, and Safety (EHS) standards.

• Communicate and support continuous improvement opportunities within daily work.

• Troubleshoot equipment and analytical methods when necessary.

• Support lean lab initiatives, including 5S activities.

• Apply scientific principles related to testing drug substances and drug products, including understanding

how chemistry interacts with lab equipment.

• Maintain lab inventory, including supplies and consumables.

Requirements

• High School Diploma with relevant chemistry laboratory experience or

• Associate degree in Chemistry, Biology, or Microbiology

Preferred Qualifications

• Experience using a Laboratory Information Management System (LIMS).

• Strong problem-solving and analytical-thinking skills.

• Excellent interpersonal and networking abilities.

• Experience working in a GMP QC laboratory environment.

• Strong written and verbal communication skills.

• Exceptional attention to detail.

• Ability to manage and prioritize multiple tasks.

• Ability to provide on-call support when needed.

• Demonstrated ability to work independently and collaboratively.

RTD Biosciences is building a next-generation peptide manufacturing and analytical testing laboratory, and we are looking for a Lead Analytical Chemist / Lead Laboratory Technician to help build and operate the lab from the ground up.

This is a hands-on leadership role for a scientist who enjoys working with analytical instrumentation, solving complex technical problems, and helping establish laboratory systems in a growing pharmaceutical manufacturing environment.

You will play a key role in analytical testing, method development, manufacturing support, and regulatory compliance as we expand our operations.

What You'll Do:

Analytical Testing

• Operate HPLC, LC-MS/MS, and Q-TOF systems for peptide identity, purity, and potency testing
• Perform CoA testing including assay, related substances, endotoxin, sterility, and particulate analysis
• Develop and optimize analytical methods aligned with USP and FDA expectations

Manufacturing Support

• Support peptide production including formulation, sterile filtration, and lyophilization
• Execute batch records and perform in-process testing
• Troubleshoot formulation and stability issues

Quality & Compliance

• Author and maintain SOPs, analytical methods, and quality documentation
• Support FDA inspections and regulatory readiness
• Participate in deviation investigations and CAPA

Laboratory Leadership

• Coordinate sample testing workflows
• Train and mentor laboratory technicians
• Manage lab inventory, reagents, and equipment maintenance

Qualifications:

Required

• Bachelor’s degree in Chemistry, Biochemistry, or Pharmaceutical Sciences
• 5+ years of analytical laboratory experience
• Hands-on experience with HPLC systems
• Knowledge of cGMP and USP laboratory testing

Preferred

• Experience with LC-MS/MS or mass spectrometry
• Experience with peptides, biologics, or injectable drug products
• Background in 503B outsourcing facilities or sterile compounding
• Cleanroom or aseptic processing experience

Compensation:

$90,000 – $115,000 salary + performance bonus. Some room for negotiation based on experience.

Benefits include:

• Health, Dental, Vision
• 401(k)
• PTO
• Life Insurance
• Professional development support
• Advancement pathway to Laboratory Manager

To apply, please submit your resume and a brief cover letter describing your relevant

Senior Andrologist (California CLS Required) – Fertility Clinic

Job Summary

The Senior Andrologist is responsible for performing and overseeing advanced andrology and reproductive laboratory procedures within a fertility clinic setting. This role supports male fertility evaluation, endocrine testing, and assisted reproductive technologies (ART) by performing semen analyses, sperm preparation, and hormone testing while ensuring compliance with California laboratory regulations.

The Senior Andrologist also supervises andrology laboratory operations, maintains quality control standards, and collaborates closely with reproductive endocrinologists, embryologists, and clinical staff to support patient care.

Key Responsibilities

Andrology Laboratory Testing

• Perform diagnostic semen analysis according to WHO guidelines and laboratory protocols.
• Conduct advanced sperm function testing including:
• Morphology assessment
• Motility and vitality analysis
• Sperm concentration and total motile count
• DNA fragmentation testing when applicable
• Prepare sperm samples for assisted reproductive technologies (ART) including:
• Intrauterine Insemination (IUI)
• In Vitro Fertilization (IVF)
• Intracytoplasmic Sperm Injection (ICSI)
• Process surgical sperm retrieval samples including TESA, PESA, and micro-TESE.

Endocrinology & Hormone Testing

• Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
• Operate immunoassay analyzers including Roche Cobas e411 for hormone testing (e.g., FSH, LH, Estradiol, Progesterone, AMH, Testosterone, hCG, Prolactin).
• Perform linearity verification and calibration verification (CALVER) as required by laboratory validation protocols.
• Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH regulations.
• Troubleshoot analyzer performance issues and perform corrective actions as needed.
• Perform routine and scheduled instrument maintenance, calibration checks, and functional verification of the analyzer.
• Monitor assay performance and maintain quality documentation for regulatory inspections.

Sperm Banking & Cryopreservation

• Perform sperm cryopreservation and thawing procedures for fertility preservation and donor banking.
• Maintain specimen tracking and chain-of-custody documentation.
• Ensure compliance with CAP, CLIA, FDA tissue regulations, and California Department of Public Health (CDPH) requirements.

Laboratory Operations & Quality Management

• Maintain compliance with California Clinical Laboratory licensing regulations.
• Implement and maintain laboratory quality assurance and quality control programs.
• Perform method validation, verification, and instrument performance checks.
• Assist with preparation for CAP, CLIA, and CDPH laboratory inspections.
• Maintain laboratory documentation, standard operating procedures (SOPs), and regulatory records.

Leadership & Training

• Supervise and train andrology and laboratory technologists.
• Ensure staff competency and continuing education compliance.
• Assist in development and updates of laboratory SOPs.
• Participate in laboratory audits and regulatory readiness activities.

Clinical Collaboration

• Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff.
• Provide consultation regarding male fertility testing, sperm preparation methods, and endocrine laboratory results.
• Participate in multidisciplinary patient case discussions and treatment planning.

Required Qualifications

Education

• Bachelor’s degree or higher in Clinical Laboratory Science, Biology, Biochemistry, or related field.

Licensure

• Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH).

Experience

• 5+ years of laboratory experience, preferably in fertility, andrology, or reproductive medicine laboratories.
• Experience performing semen analysis, sperm preparation for ART, and hormone immunoassay testing.
• Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers.

Preferred Qualifications

• Experience working in IVF or assisted reproductive technology laboratories.
• Familiarity with CAP accreditation standards, CLIA requirements, and CDPH regulations.
• Experience with instrument validation, proficiency testing programs, and regulatory inspections.

Key Skills

• Advanced knowledge of male fertility diagnostics and semen analysis techniques
• Expertise in ART sperm preparation methods
• Strong knowledge of endocrinology testing and immunoassay instrumentation
• Ability to troubleshoot laboratory instruments and perform technical maintenance
• Thorough understanding of CAP, CLIA, and CDPH regulatory compliance
• Strong attention to detail and laboratory documentation practices
• Effective leadership and communication skills

Work Environment

• Fertility clinic laboratory setting
• Handling of human reproductive specimens and biological materials
• May require early morning, weekend, or on-call work depending on clinical schedules