Sr. Manager, Quality Compliance Audits
Mannkind Corporation job in Danbury, CT
MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life. At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company's entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly. Our Values serve as the foundation of MannKind's culture. They define who we are, how we act, and guide our interactions every day-both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together. This position can be based out of either Danbury, Ct or Burlington, Ma Job Summary Manages the coordination and preparation of GxP and ISO internal and external audits in accordance with the regulatory standards and using sound judgement in assessing compliance risks. Interactions normally involve matters between functional areas or other company divisions/units and customers. Performs audits, act as lead auditor as well as identifies resources and define plans for other auditors. Essential Job Responsibilities:
Complete auditor qualification using On-the-Job-Trainings where competency in completing auditing steps/ tasks/activities is demonstrated and documented.
Contribute to vendor selection; a process for the identification, evaluation and selection of external providers of goods and services that takes into account quality, business and technology aspects of a vendor's ability to meet defined requirements.
Manages the external audit program for vendors and contract facilities that have direct or in-direct impact on a cGMP/1SO/MDSAP process including drug product, delivery system, and related packaging to ensure compliance to requirements, regulations, and standards.
Maintains the GLP audit program; approving or reapproving Contract Research Organizations (CROs), and/or GLP vendors for compliance, internal company requirements, and other standards.
Maintains the GCP/PV external audit program; audit process of clinical investigators and trial sites, contract research organizations / vendors and related entities providing Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) services to MannKind Corporation.
Maintains the approved vendors list; a list of approved vendors, contract organizations and service providers deemed suitable for use based upon auditing performed.
Manages quality agreements; contract between two parties that identifies specific, agreed upon roles and responsibilities for assurance of a quality commodity or service. Provide a listing of all current agreements and their status as a component of the Annual Product Review submitted the Agency.
Manage supplier change notifications; a notification of a change provided to MannKind by a supplier/vendor that, per the Quality Agreement, does not require MannKind's approval to proceed.
Manage supplier relationship regarding non-conforming materials, deviations and CAPA. Develops and utilizes vendor performance metrics of which are reported on in management review.
Manages the internal audit program that tracks compliance to internal quality systems and company procedures. Audit program applies to all cGMP/1SO/MDSAP regulated operations and areas.
Quality Control (QC) of regulatory submissions; the process for performing review of documents in support of a regulatory submission or clinical quality oversight.
Maintenance of regulations, standards, and guidance's - types of documents of external origin.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player. Qualifications:
BA/BS degree in a scientific discipline with 10-12 years or MS/MBA degree with 6-8 years related experience or the combination equivalent of training and experience.
10-12 years of experience, preferably in pharmaceutical industry or a regulated environment.
Required knowledge of GxP Compliance and ISO standards.
Previous management, supervisory, or project coordination experience is required.
Proficiency in MS Word, Excel and PowerPoint.
Excellent communication skills both written and verbal.
Strong interpersonal skills. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
Sr. Manager, Clinical Supply Chain
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Job Summary:
As a Clinical Supply Chain Sr. Manager, you will play a pivotal role in ensuring efficient delivery of high-quality clinical trial supplies for all early and late-stage MannKind clinical trials worldwide. Your responsibilities will include managing the packaging, labelling, distribution, and destruction of clinical supplies. You will work collaboratively with internal quality assurance, packaging technology, program management, clinical manufacturing, manufacturing supply chain, and internal manufacturing teams on overall trial demand. Externally, you will manage CMO/CRO partners responsible for kitting, labeling, distribution, site management, and IMP destruction, ensuring compliance throughout the supply chain
Job Responsibilities:
* Oversee all operational aspects of the clinical supply chain.
* Review clinical protocols and design proper supply chain strategies.
* Collaborate with the clinical team to configure, set up and support Interactive Response Technology (IRT) Systems.
* Develop global SOPs and processes for trial materials globally.
* Solve study/project level technical and business issues of trial materials.
* Oversee packaging and labeling activities for clinical trial materials in compliance with Good Manufacturing Practices (GMP).
* Manage global supply inventory depot strategy, from start to implementation.
* Provide consistent CMC and Core Study team updates on supply progress and strategy, communicating challenges and collaborating on solutions to mitigate trial risks.
* Ensure compliance with the ETMF documentation.
* Support any required regulatory documentation requests.
* Observe all Company, Health, Safety and Environmental guidelines.
Job Qualifications:
* Bachelor's degree in supply chain management, logistics, science and technology, or another related field.
* 5-7 years of experience in clinical supply chain.
* Strong organizational skills with diligence and accuracy in inventory tracking.
* Proficient in inventory management and clinical planning tools (ERP systems, MS Excel, RTSM systems, IXRS/IRT, etc.).
* Experience with reconciling inventory and managing IMP destructions worldwide.
* Ability to analyze production schedules and forecast material demand.
* Effective communication and collaboration skills with cross-functional teams.
* Strong time-management skills and the ability to prioritize tasks in a challenging environment.
* Knowledge of Medidata and/or Microsoft Dynamic 365 a plus.
* Ensure compliance with the ETMF documentation.
Psychiatrist (Emergent Psychiatry, Hospital Based)
Grovetown, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Job Title: Emergent Psychiatrist
Location: Columbia County, GA
Employer: Wellstar Health System - Columbia County
About Wellstar Health Systems:
Wellstar Health Systems is a leading healthcare provider dedicated to delivering high-quality, compassionate care across Georgia. Our newest hospital in Columbia County is committed to innovation and excellence, aiming to serve our community with comprehensive medical and psychiatric services.
Position Summary:
Wellstar Health Systems seeks a board-certified Emergent Psychiatrist to join our dynamic team at our newest hospital in Columbia County. The Emergent Psychiatrist will provide expert psychiatric assessment, diagnosis, and management of patients presenting with acute psychiatric emergencies in our Emergency Department and inpatient units. The successful candidate will collaborate closely with multidisciplinary teams to ensure timely, compassionate, and evidence-based psychiatric care.
Key Responsibilities:
Conduct psychiatric evaluations and risk assessments for patients presenting with psychiatric emergencies.
Develop and implement treatment plans for emergent psychiatric conditions including mood disorders, psychosis, substance intoxication/withdrawal, and suicidal ideation.
Provide crisis intervention and stabilization for patients in the Emergency Department and inpatient settings.
Collaborate with emergency medicine physicians, nursing staff, social workers, and other healthcare professionals to coordinate care.
Prescribe and manage psychiatric medications in accordance with best practices and hospital policies.
Participate in multidisciplinary rounds and case conferences to optimize patient outcomes.
Ensure accurate and timely documentation of psychiatric evaluations and treatment plans.
Maintain compliance with regulatory and accreditation requirements related to psychiatric care.
Engage in ongoing professional development and contribute to hospital education programs as needed.
Qualifications:
MD or DO degree from an accredited medical school.
Board certification or eligibility in Psychiatry with additional training or experience in Emergency Psychiatry preferred.
Valid medical license to practice in Georgia or eligibility for licensure.
Demonstrated expertise in managing acute psychiatric emergencies.
Excellent clinical judgment and strong communication skills.
Ability to work effectively in a fast-paced, multidisciplinary environment.
Commitment to patient-centered, culturally sensitive care.
Why Join Wellstar Health Systems?
Be part of a rapidly growing, innovative health system dedicated to community health.
Access to state-of-the-art facilities and resources at our newest Columbia County hospital.
Competitive compensation and comprehensive benefits package.
Supportive work environment fostering professional growth and collaboration.
Application Process:
Interested candidates are invited to submit a CV and cover letter outlining their qualifications and interest in the position to **************************.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Radiation Therapist, FT Days
Marietta, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America)
Competitive Sign-on Bonuses and Relocation Assistance Available - Apply Today!
Job Summary:
The Staff Radiation Therapist in the Radiation Oncology Department applies ionizing radiation to a diverse population of patients in accordance with the prescription and instructions of the Radiation Oncologist. They must be capable of operating radiation-producing equipment utilizing radiation safety measures and be able to perform a series of complex and precise technical procedures.
Core Responsibilities and Essential Functions:
Participates in Quality Control monitoring.
- a.Delivers consistent precise therapy to a designated treatment area.
- b.Demonstrates skill in patient assessment, performing procedures and giving specialty care to patients, considering the age of the patient and appropriately adopts care for age (adolescent, adult and geriatrics).
- c.Documents appropriately in Electronic Medical Record (EMR)
- d.Demonstrates a willingness to perform additional tasks and gives assistance when necessary to others.
- e.Recognizes own limitations and/or needs and seeks assistance as needed.
- f.Reports adverse reactions to physician immediately and follows policy and procedure (P/P) for documentation.
- g.Educates patient/family on expected side effects, use of blocks, wedges and other treatment aids.
- h.Follows P/P to ensure precise treatment per physician prescription.
- i.Follows P/P to ensure precise treatment per physicists instruction in chart or computer. Follows proper procedure to ensure safety to self and patient.
- a.Assesses mobility of patients and manages accordingly, looks at EMR for fall precautions.
- b.Wears radiation safety badges at all times.
- c.Practices universal precautions.
- d.Participates in daily warm-up procedures to ensure output is within tolerances
- e.Advises manager of any discrepancies and any material item that needs replaced or fixed as soon as possible Understands and completes correctly all patient set-ups
- a.Simulates new patients and/or patients with new treatment fields with no errors and according to physicians written order in EMR.
- b.Schedules patients appropriately and always lets patient know of any changes prior to changes being made. Miscellaneous items
- a.Will do other tasks as assigned
- b.Participates in on-call rotation
- c.Is active as a student clinical instructor with both RTT and RTR students. Will evaluate and give feedback to both students and Clinical Advisor.
Required Minimum Education:
Associate's Degree Must be a graduate from an accredited Radiation therapy program Required
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
ARRT Radiation Therapy
Basic Life Support or BLS - Instructor
Additional License(s) and Certification(s):
Required Minimum Experience:
Minimum 2 years Experience in Radiation Therapy Preferred
Required Minimum Skills:
Demonstrates ability to treat/simulate patients.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Medical Oncologist Opportunity - Wellstar Columbia County Hospital
Grovetown, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America)
Wellstar Health System is seeking a Board-Certified/Board-Eligible Medical Oncologist to join our growing oncology team at Wellstar Columbia County Hospital, scheduled to open in Fall 2026 in Grovetown, Georgia-just outside of Augusta.
This is a unique opportunity to play a foundational role in delivering high-quality cancer care in a brand-new, state-of-the-art facility-backed by the strength, resources, and reputation of Wellstar, one of Georgia's largest and most integrated healthcare systems.
Position Highlights
Provide comprehensive outpatient and inpatient oncology services in a collaborative, patient-centered model.
Participate in the development of cancer care services for the Columbia County region.
Collaborate with a multidisciplinary team of specialists including radiation oncologists, surgical oncologists, and APPs.
Opportunity for clinical trials, program development, and academic engagement.
Full-time, employed position with competitive compensation and comprehensive benefits.
Qualifications
MD or DO from an accredited medical school.
Board Certified/Board Eligible in Medical Oncology and Hematology.
Eligible for medical licensure in the state of Georgia.
Excellent communication and interpersonal skills.
Why Wellstar Columbia County?
Brand new, 100-bed hospital designed for innovation and patient comfort.
Conveniently located in one of the Southeast's fastest-growing communities.
Access to advanced technologies, robust support services, and a strong referral base.
Part of a nationally recognized health system known for its commitment to clinical excellence, safety, and innovation.
About Wellstar Health System
Wellstar is a not-for-profit health system with over 24,000 team members, 300+ medical office locations, 11 hospitals, and numerous specialty services across Georgia. We're committed to transforming healthcare and making a meaningful difference in the lives of the people and communities we serve.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Registered Nurse (RN) - 5 West Acute Care Medicine - Augusta, GA - PRN
Augusta, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America)
Job Summary:
Registered Nurses provide quality nursing services by working with the patient care team to assess, plan, implement, and
evaluate patients' care and by providing a positive, supportive environment. The Registered Nurse is the front-line
representative of the patient care team often serving as the intermediary between the patient and family, the provider(s),
and other care team members. This role is expected to: participate in performance improvement initiatives; maintain
professional competence; develop others; uphold confidentiality, safety, and professional standards; and support Shared
Governance through service on councils or sponsored activities.
Core Responsibilities and Essential Functions:
Patient Care and Care Coordination: Monitors, examines, and evaluates the patients conditions. Assists with the care plan and takes appropriate actions to promote the patients short/long-term outcomes and wellbeing. Delivers care plan as outlined, applying independent judgment where appropriate. Collaborates with and communicates patient care plans with other staff, as appropriate. Prioritizes and coordinates optimum daily patient flow and patient experience. Delivers safe and effective care according to policies and procedures. Maintains appropriate documentation of patient assessment, changes in condition, care delivered, education provided, and any incidents or exceptions related to standards of care or compliance with hospital policy. Patient Advocacy and Satisfaction: Listens to concerns, probes in-depth to understand the needs and concerns, and responds to patient needs in an appropriately timed manner. Serves as an educational resource for patients and families on health-related issues. Communicates necessary patient information to family, licensed care providers, and other staff. Embraces the concept of patient- and family-centered care to maintain patient, family, staff, and physician satisfaction. Prioritizes actions according to patient needs and provides input into the plan of care by reporting pertinent information involving the patient and family to the appropriate individuals in accordance with confidentiality standards. Performance Improvement: Seeks opportunities to improve the work environment and processes. Contributes ideas to help identify solutions and supports change implementation. Supports and contributes to improvement initiatives aligned with achieving better patient quality outcomes, patient satisfaction, staff satisfaction, and organizational financial performance. Professional Competency and Growth: Maintains professional licenses and certifications. Completes all required training. Self-identifies and self-manages training and development opportunities. Is involved in professional organizations. Keeps current with research literature and industry best practices. Seeks opportunities for professional growth and leadership development. Professional Leadership: Fosters the growth and development of other nurses through mentorship and preceptorship. Contributes to a positive and supportive work environment. Adheres to all confidentiality, safety, and professional standards. Acts with professionalism embrace shared governance principles and demonstrate integrity. Holds self and others accountable for practice by participating in the peer feedback process. Positively promotes the nursing profession and assists with the recruitment of nurses to AU Health.
Other duties as assigned.
Required Minimum Education:
Associates Nursing or Bachelors Nursing-Preferred
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
Basic Life Support or BLS - Instructor
Reg Nurse (Single State) or RN - Multi-state Compact
Required Minimum Experience:
Minimum 1 year nursing experience is required for PRN.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Ultrasonographer - Westbrook
Westbrook, CT job
Highlights
Department: Diagnostic Imaging - Shoreline
Hours: 30 hours/week
Shift: Days, 1st shift
Using independent judgment, the Ultrasonographer performs a variety of ultrasound exams in work environments that may include interventional procedures and operating rooms.
Assists physicians and provides patient care essential to ultrasound procedures.
Exercises professional judgment in the performance of procedures.
Applies the principles of teamwork in all aspects of patient care and service delivery.
Minimum Requirements:
ARDMS Certified
Must hold or be willing to obtain a breast certification within 1 year of hire.
Excellent attendance record and flexibility with scheduling are a must.
Demonstrates technical expertise and competency in all ultrasound procedures.
Demonstrates flexibility and promotes teamwork inter and intradepartmental.
Comprehensive Benefits Offered:
Competitive and affordable health benefits (total rewards package)
403(b) retirement plan with company matching
Paid holidays, time off and sick time
Wellness rewards program
Quick commute access from I-84, I-91, Route 9 and surrounding areas
Free parking with shuttle drop-off service
…and much more!
About Middlesex Health
The Smarter Choice for your Career!
Come join one of Connecticut's Top Workplaces, and a Magnet designated organization! At Middlesex Health, we have a unique combination of award-winning talent, world-class technology, and patient-first care that's making health care better. Through our affiliation with the Mayo Clinic Care Network, Middlesex Health has access to the most advanced medical knowledge and research available.
Medical Technologist - Microbiology
Middletown, CT job
Highlights
Department: Laboratory
Hours: Per Diem
The Medical Technologist (ASCP) - Microbiology performs complex analytical procedures
within the laboratory using practical and theoretical knowledge of clinical procedures and
instrumentation. Phlebotomy is performed by dedicated phlebotomists at all sites. Responsible
for limited microbiology testing (no plate reading) and molecular testing.
Minimum Qualifications:
Bachelor's Degree with MT/MLS (ASCP) Generalist certification, ASCP(M) or Associate's Degree with MLT (ASCP) Generalist certification
Preferred Qualifications:
Epic Beaker Experience
Familiarity with current instrumentation
Benefits of Working at Middlesex Health Laboratory: Our video says it all. Please take a moment to watch. ***********************************************
Comprehensive Benefits Offered:
Competitive and affordable health benefits (total rewards package)
403(b) retirement plan with company matching
Paid holidays, time off and sick time
Wellness rewards program
Quick commute access from I-84, I-91, Route 9 and surrounding areas
Free parking with shuttle drop-off service
…and much more!
About Middlesex Health
The Smarter Choice for your Career!
Come join one of Connecticut's Top Workplaces, and a Magnet designated organization! At Middlesex Health, we have a unique combination of award-winning talent, world-class technology, and patient-first care that's making health care better. Through our affiliation with the Mayo Clinic Care Network, Middlesex Health has access to the most advanced medical knowledge and research available.
Neurosurgeon - Wellstar Columbia County Hospital (Opening Fall 2026)
Grovetown, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Various (United States of America)
Wellstar Health System, one of Georgia's largest and most respected health systems, is seeking a Board-Certified/Board-Eligible Neurosurgeon to help launch and lead the neurosurgical program at the brand-new Wellstar Columbia County Hospital, opening in Fall 2026 in Grovetown, Georgia.
Opportunity Highlights
General neurosurgery with flexibility to develop subspecialty interests (spine, cranial, trauma, etc.)
Brand-new operating rooms with advanced imaging, robotics, and neuro-monitoring
Full-time APP and clinical team support
Integrated EPIC EMR system across the Wellstar enterprise
Support from strong hospitalist, neurology, trauma, and intensivist teams
Inpatient and OR-based practice on a Level III Trauma Center campus
Ability to shape clinical protocols, referral relationships, and program growth
Qualifications
MD or DO from an accredited program
Completion of accredited neurosurgery residency; fellowship training welcome
Board Certified or Board Eligible in Neurosurgery
Spine Experience preferred
Eligible for Georgia medical licensure
Strong communication skills and a collaborative, program-building mindset
Compensation & Benefits
Competitive salary with productivity incentives
Comprehensive benefits package including medical, dental, vision, malpractice, and retirement
Generous CME allowance and relocation assistance
Paid time off and protected CME days
Why Wellstar Columbia County?
Located in Grovetown, GA, just outside Augusta, Columbia County is one of the fastest-growing communities in the state, offering highly ranked public schools, affordable housing, and access to outdoor recreation. The new Wellstar Columbia County Hospital will serve as a regional medical hub and is poised to redefine care delivery.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
7662 - Respiratory Therapist II PRN CH NF
Austell, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Night (United States of America) Job Summary: The Respiratory Therapist III is responsible for medication administration and implementing respiratory care based on expanded knowledge, experience, and the evaluate-and-treat process. The RT III is responsible for delivering patient care in complex, multiple problem-patient care situations. The majority of time is in critical care areas with protocol ventilator management, significant independent decision-making and self direction. In addition, to patient care delivery, the RT III is responsible for patient, family/support system education, coordination of activities, staff development, and professional and self-developmental activities. The RT III is responsible for providing patient care with an understanding and awareness of population specific needs. The RT III addresses the biological, emotional, and developmental, psychosocial, and patient/family education needs when providing care to the patient. Promotes and models RT best practices. Actively engages in PI projects. Demonstrates ability and willingness to serve in a preceptor capacity for new employees and RT students. Core Responsibilities and Essential Functions: 1.Provides Customer Service a. Completion of patient care, documentation and education b. Team approach to service c. Promotes a team spirit and positive work environment d. Provides supportive environment for students and staff 2. Administers Quality Patient Care a. Performs patient assessment & assessment for therapy b. Collaborates with health care team members in planning patient care c. Verifies orders and administers aerosolized medication, bronchial hygiene, volume expansion, oxygen & medical gas therapy d. Performs ventilator management, weaning, wave form graphic interpretation; airway management (intubation, extubation, trach tube change and care) e. Performs arterial blood gas sampling & analysis f. Educates patient and mentors/precepts new employees, students and peers g. Location Specific: Assisting in invasive and non-invasive procedures, Cardiac Service procedures, Pulmonary Diagnostic Testing 3. Provides Safe & Quality Environment a. Promotes current and accurate electronic orders, charting and charging b. Promotes high level of patient safety (Medication Safety, NPSG, etc) c. Promotes Performance Improvement initiatives designed to promote quality care d. Promotes evidence-based practice e. PI Projects f. Reviews the revised and new DPPs Performs other duties as assigned Complies with all Wellstar Health System policies, standards of work, and code of conduct. Required Minimum Education:
Associates Respiratory Therapy or Bachelors Respiratory Therapy-Preferred
Required Minimum License(s) and Certification(s): All certifications are required upon hire unless otherwise stated.
RCP - Respiratory Care Prof
NBRC-RRT - Registered Respiratory Therapi
BLS - Basic Life Support or ARC-BLS - Amer Red Cross Basic Life Support or BLS-I - Basic Life Support - Instructor
ACLS - Advanced Cardiac Life Support or ARC-ALS - Amer Red Cross Advanced Life Support or ACLS-I - ACLS - Instructor
PALS - Pediatric Adv Life Support or ARC-PALS - Amer Red Cross Pediatric Advanced Life Support or PALS-I - PALS - Instructor
NRP - Neonatal Resuscitation Program or ARC-NALS - Amer Red Cross Neonatal Advanced Life Support or NRP-I - NRP - Instructor or NRP-P - NRP-Provisional (180 Days) within 180 Days
Additional License(s) and Certification(s): Required Minimum Experience: Current advance credential with a minimum of two (2) years clinical experience to work in all critical care areas but not limited to Adult ICU, CVICU, BURN, NICU, Emergency Departments (Adult and Pediatric) as it relates each facility. Required Required Minimum Skills: Ability to communicate well, critical thinking skills, establish and maintain working relationships with physicians and other health care personnel professionals, and computer skills including familiarity with databases. Good customer relation, assessment, and communication skills are a must for this job.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Physician - Interventional Cardiologist - Columbia County, GA
Grovetown, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America)
Wellstar Health System is seeking a board-certified/board-eligible Interventional Cardiologist to join our growing and dynamic cardiology team in Columbia County, Georgia. This position offers the opportunity to practice in a collaborative and patient-focused environment with access to advanced technology, supportive staff, and a robust referral network.
This is an excellent opportunity for an experienced or early-career physician who is committed to clinical excellence, compassionate care, and strong interventional outcomes.
Provide inpatient and outpatient interventional cardiology services
Perform a full range of interventional procedures
Share in call coverage with other cardiology physicians in the region
Collaborate with a multidisciplinary team including cardiologists, advanced practice providers, and cardiac imaging specialists
Participate in quality improvement initiatives and cardiovascular program development
Qualifications:
MD or DO degree from an accredited medical school
Board certified/board eligible in Cardiology and Interventional Cardiology
Completion of an ACGME-accredited fellowship in Interventional Cardiology
Eligible for medical licensure in the state of Georgia
Commitment to excellence in patient care, teamwork, and professional development
Why Wellstar - Columbia County:
Access to state-of-the-art cardiac cath lab and imaging technology
Support from one of Georgia's largest and most integrated health systems
Competitive compensation and comprehensive benefits
Robust onboarding and support services
Opportunities for academic involvement, research, and leadership
Wellstar Health System is recognized nationally for innovative care models, excellence in cardiovascular medicine, and dedication to improving community health outcomes.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Speech Pathologist FT Days Acute Care Therapies
Marietta, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America)
Job Summary:
The Speech Language Pathologist Fellow evaluates patients and develops the speech/language plan of care in the areas of speech, language, voice, cognition and swallowing in collaboration with the physician and care team. Receives supervision, as required by ASHA, which includes reviewing diagnostic reports/treatment records/plans of treatment, monitoring the Clinical Fellow's participation in case conferences/professional meetings and/or evaluating work by consulting with colleagues, clients and their families. Services are provided across the full continuum and rendered in a cost conscious, quality focused and customeroriented manner. Compliance with all applicable regulatory standards is required in this role.
Core Responsibilities and Essential Functions:
Patient Assessment
- In collaboration with the physician, responsible for the establishment and ongoing evaluation of treatment programs, plan of care, goals and discharge plans for the patients as related to speech, language, cognition, voice and swallowing.
- Establishes a plan of care in conjunction with the patient and/or family members.
- Establishes realistic discharge plan incorporating patient and/or family member goals. Treatment Planning and Provision of Care
- Implements the speech language therapy treatment plan
- Selects appropriate treatment activities to progress patient towards goals.
- Revises goals/plan of care with patient/family input
- Provides ongoing patient/family education and training
- Provides discharge instructions, follow-up and referral to community resources as appropriate
- Acts as a referral source for staff, families, physicians on services and equipment related to rehabilitation services. Documentation
- Documents the evaluation and plan of care according to departmental guidelines
- Documents each treatment session according to departmental protocols
- Completes and submits family education, discharge and other required documentation within facility and program guidelines General requirements
- Adheres to ethical business practices by striving to perform in a manner that conforms to the highest standards of ethical behavior, integrity and honesty.
- Embraces diversity and demonstrates the ability to work together.
- Maintains confidentiality of all patient information.
- Maintains attendance/punctuality in accordance with system policy and procedure.
- Adheres to departmental dress code policy, including wearing and displaying ID badge appropriately.
- Communicates information effectively both verbally and in writing with all team members. Attends and participates in staff meetings, required inservices, process improvement activities, and other meetings as requested.
- Organizes workload to complete responsibilities in an appropriate and timely manner.
- Utilizes materials and equipment in a safe and cost-effective manner.
- Observes infection prevention precautions Customer Service
- Strives to help lead the industry through vision, technology, innovation and customer service. Strives to make a difference in the lives of our employees and patients.
- Consistently applies AIDET principles in all interactions with patients.
- Encourages a positive environment and experience for co-workers and patients. Treats patients and fellow team members with respect. Fosters teamwork with trust, support and collaboration.
- Demonstrates knowledge of service recovery principles and implements appropriately Professional Development
- Participates in professional development and mandatory education activities.
- Completes core and annual competencies according to established departmental timelines.
- Completes all educational requirements required by discipline to maintain licensure.
- Participates in orientation and training of new employees.
- Completes all mandatory hospital and/or system mandatory requirements
Required Minimum Education:
Graduate from an accredited speech-language pathology program. Required and
Master's Degree in Speech-Language Pathology or other related degree. Required
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
Speech Language Pathologist
Basic Life Support or BLS - Instructor
Additional License(s) and Certification(s):
Required Minimum Experience:
Required Minimum Skills:
Effective communication skills,
customer service focused,
team oriented, and
basic computer skills.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Engineer II, Desktop Support Center (Contract to Hire)
Mannkind Corporation job in Danbury, CT
At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary:
Located at our manufacturing facility in Danbury, CT and reporting to the Sr. Manager, Information Technology, the System Engineer II is responsible for the daily operations of computer hardware, software and cloud applications. Responsible for all levels of troubleshooting technical issues related to hardware and software. Installs software upgrades and configuration changes when required. Runs diagnostics on computer hardware. Responsible for tracking hardware and software asset inventories. Follows through on technical issues until closure.
Principal Responsibilities:
* Provide lead technical support for computer hardware, operating systems, telephony systems,
and the corporate network.
* Provide technical assistance, troubleshooting support, and general systems guidance to office and remote end users.
* Perform specialized tasks to maintain computer equipment and their peripherals.
* Able to effectively communicate with business owners at all levels.
* Install new software and manage software upgrades.
* Maintain computer and software inventories.
* Manage image preparation and deployment for all hardware types.
* Provide system administrator skills to general systems such as McAfee, Malwarebytes, O365, etc.
* Perform special projects, as assigned by IT management.
* On-call rotation is required.
Education and Experience Qualifications:
* BA/BS degree with at least 3 years related experience or the equivalent combination of training and experience.
* Formal training in Microsoft support and the Office Suite
* Experience with MDM and Apple device management desired
* Experience with imaging systems such as SCCM, Ghost, iDrive, etc.
* Microsoft certification or similar from other vendors
* Experience in Computer System Validation desired
* Excellent problem solving skills
* Ability to work effectively under pressure
* Excellent interpersonal and communication skills
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza (insulin human) inhalation powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit *********************
Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.
Supervisor, Quality Control
Mannkind Corporation job in Danbury, CT
At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Job Summary
Develops, implements and maintains the activities of quality control systems. Oversees methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Contributes information to help develop budgets. Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations.
Essential duties and key job responsibilities and essential functions.
Provide general or direct supervision to exempt employees and/or skilled nonexempt employees
Act as advisor to unit or sub-units, becomes actively involved as required to meet schedules or resolve problems
Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities
Exercise judgment within defined procedures and policies to determine appropriate action. Critically review data for anomalies or trends and approve data
Lead and approve investigations of suspect or out of specification results. Ensures implementation of CAPA.
May perform bench analysis, as needed
Frequently interacts with subordinates, outside customers, and functional peer groups at various management levels
Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc. Contributes to cross functional projects with significant impact to company
Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.)
Section III: Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training
Must have experience with HPLC
Must have Empower experience
Proficiency in MS Word, Excel, and PowerPoint
Strong interpersonal and organizational skills
Supervisory experience
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
Specialist I, Archive Specialist (6-8 Month Contract)
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. We are seeking a detail-oriented Contract Archive Specialist to support a document clean-up initiative within our quality archive. This role will focus on organizing, reviewing, and facilitating the removal of legacy documents in accordance with internal retention policies and regulatory requirements. The ideal candidate will have experience in GxP environments and a strong understanding of document lifecycle management. Key Responsibilities:
Review archived physical documents to identify legacy materials eligible for removal.
Apply document retention schedules and ensure proper classification of records.
Prepare documentation for record destruction.
Support reorganization of archive structure for improved accessibility and compliance.
Ensure all activities are performed in alignment with applicable GxP regulations and internal SOPs.
Maintain accurate records of all actions taken during the clean-up process.
Any other tasks/activities as assigned by the supervisor/manager.
Qualifications:
Bachelor's degree or equivalent experience in Life Sciences, Information Management, or related field.
2+ years of experience in document or archive management, preferably in a pharmaceutical or biotech setting.
Familiarity with GxP requirements and document retention practices.
Strong organizational skills and attention to detail.
Ability to work independently and manage time effectively.
Preferred Skills:
Experience with legacy document clean-up or archive restructuring projects.
Knowledge of regulatory requirements for document retention and destruction.
Comfortable handling confidential and sensitive information.
Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to 9pm
Mannkind Corporation job in Danbury, CT
About MannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more. Job Summary:
Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes finished formulations, raw materials, in process materials, or stability samples by HPLC/GC, in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. Working Hours: 12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays.
Essential duties and key job responsibilities and essential functions.
Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures.
Perform chemical analyses of product to ensure stability.
Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
Calibrate and maintain lab equipment.
Participate in the preparation of investigations, summaries and reports.
May assist in developing testing methods.
Review data obtained for compliance to specifications and report abnormalities.
Revise and update standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
Follows written test methods and protocols.
Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data. Professional interactions are primarily within the QC organization.
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
BS Degree in a scientific discipline with minimum of 4-6 years related experience or Masters with 2-4 years or an equivalent combination of training and experience
At least 5+ years' experience in a laboratory setting, preferably in pharma
Minimum 5+ years' experience in quality control systems
Must have Empower experience
Good written communication skills
Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred
Good interpersonal skills
Access, Excel, Word and Power Point skills
Specialist I, Quality Assurance Floor (3rd Shift, 10pm - 6:30am, M-F) Temp to Hire 6-8 Months
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Job Summary: Ensures processes and products conform to established company and regulatory standards. Reviews, analyzes and reports on quality discrepancies related to manufacturing and testing of product and company systems. Investigates problems and recommends disposition and corrective actions for recurring discrepancies. Uses predetermined methods, operations and procedures to inspect and test raw materials, work-in-process, finished product as applicable. **3rd Shift, 10pm - 6:30am, M-F. Temp to Hire 6 to 8 Months** Essential Duties:
Identify, communicate and escalate basic technical issues.
Identify options for resolutions and lead implementation of corrective actions.
Prioritize own work and works independently on day-to-day activities, additional supervision/guidance for new assignments.
Point of contact on the manufacturing floor as needed
Review executed batch records - real time remediation to prevent deviation (e.g., GDP, settings, alarm response)
Perform QA activities in the batch record.
Verify entries occur real time in batch records
Perform QC/Retain sampling for each batch
General observations regarding procedural compliance of staff.
Observe the gowning and flow of materials and people.
Review all operations for the batch were performed accordance with BR.
Identify, communicate and escalate compliance issues, identify options for resolutions
Perform data entry and execute records in electronic systems.
Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualifications:
HS/GED with 2-3 years' experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 1-2 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience.
Knowledge of GxP Compliance and ISO standards.
Ability to work autonomously to problem-solve, demonstrating excellent analytical skills
Excellent written and verbal communication skills.
Physical Required
Must be willing and able to receive medical clearance to wear a respirator (i.e. Powered Air Purifying Respirator) for entire working shift.
Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e. Tyvek jumpsuit).
Engineer I, Process Development
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. We are seeking a highly motivated engineer to join the Process Development group supporting the small-molecule process development of respiratory drug products in the MannKind pipeline. The candidate is expected to support the development of our novel pulmonary formulations through contribution to the CMC project teams and must be able to meet development goals within ambitious timelines. The work environment is highly collaborative, requires excellent communication skills and the ability to be part of a cross-functional product development team. Responsibilities:
Development and optimization of manufacturing processes from bench scale to commercial scale.
Design, conduct, evaluate and interpret scientific studies to drive the development and understanding of our inhaled dosage forms.
Support technology transfers to commercial manufacturing.
Support equipment and process validation.
Manufacture of development batches and GMP clinical lots.
Assist in the management and troubleshooting of manufacturing operations, including product development studies and reviewing batch records.
Author protocols, pharmaceutical development reports, SOPs, and other scientific/technical documents, which may support regulatory filings.
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Responsible for observing all Company, Quality Assurance guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Skills and Attributes:
Exceptional scientific, technical, and problem-solving skills with the ability to design experiments and interpret data independently.
Demonstrate an understanding of process development, analytical chemistry and drug product characterization.
Knowledge of statistical analysis tools, in particular experimental design, and interpretation of complex data sets.
Excellent technical laboratory skills.
Excellent oral and written communication skills.
Ability to think strategically and creatively.
Experience with inhaled pharmaceutical products is a plus.
Competency in the principles and practice of cGMPs for drug product manufacturing is a plus.
Knowledge of materials science is a plus.
Experience with process scale-up or working across process scales is a plus.
Experience with manufacturing clinical and commercial drug products is a plus.
Familiarity/experience with particle engineering and/or wet-stirred media milling and spray drying is a plus.
The role may require lifting 50 lbs and standing for long periods of time.
Education and Experience:
BS/BA in Chemical Engineering, Materials Science/Engineering, Chemistry, Pharmaceutical Sciences or a related field. 2+ years of relevant experience is preferred.
Ability to work in a laboratory and manufacturing facility that handles active pharmaceutical ingredients.
Must be authorized to work in the United States for any employer without the need for sponsorship.
Physician- Hospital Medicine- NEW HOSPITAL Columbia County Hospital
Grovetown, GA job
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Job Summary:
Wellstar MCG Health is looking for a hospitalist to join the inagural team of the Wellstar Columbia County Hospital. Wellstar Columbia County Medical Center is anticipated to open in the fall of 2026. This full-service acute care hospital will feature 100 inpatient beds; an emergency department expected to become a Level II trauma center; a surgical platform that will include operation rooms, catheterization laborites, and interventional radiology and endoscopy. There will be a 90,000- square-foot medical office building that will offer primary care, women's health care and other specialties.
Physician provide clinical services to patients consistent with their training and expertise. The care of patients is the highest priority in the WellStar Health System.
Core Responsibilities and Essential Functions:
Clinical Practice of Medicine, Surgery, or Dentistry including
* The care of patients in Inpatient settings.
* The documentation of clinical care
* The documentation and tasks necessary for billing and other administrative functions
* Continuing Medical Education required to maintain licensure and Board Certification
Performs other duties as assigned
Complies with all WellStar Health System policies, standards of work, and code of conduct.
Required Minimum Education:
A MD or DO Degree Required and
Applicants must be licensed or eligible for licensure in the State of Georgia Required and
Applicants must have completed the necessary Residency training requisite and be Certified or qualified for Certification by their respective specialty Board Required
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
Additional License(s) and Certification(s):Required Minimum Experience:
Previous practice experience in a Residency Training Program Required
Required Minimum Skills:
It is expected that applicants will possess skils commensurate with their given specialty.
Applicants will be expected to show proof of competency for clinical skills applied for.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Manager, Logistics and Warehouse Operations
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
With the acquisition of ScPharmaceuticals, MannKind has expanded into the cardiometabolic space, adding FUROSCIX to its portfolio and reinforcing its commitment to innovative, patient-centric solutions across chronic and complex conditions.
Job Summary:
The Warehouse Operations Manager is responsible for the Warehousing, Shipping, and Receiving functions and ensuring compliance with internal procedures and external standards are The position oversees all aspects of the company's pharmaceutical warehouse activities, including the storage and distribution of raw materials, intermediates, and finished products. The primary objective is to ensure efficient operations while maintaining strict adherence to all applicable regulatory standards, such as Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and FDA regulations.
Essential Duties:
* Team Leadership & Management:
* Direct the warehousing and receiving staff and/or functions.
* Responsible for providing regular performance feedback, development, and coaching for direct reports.
* Responsible for obtaining and maintaining a Designated Representative certification for MannKind's State Licensing program for the sale and distribution of pharmaceutical and medical devices.
* Shipping & Receiving Operations:
* Supervise receipt and shipment from suppliers.
* Assure systems are in place to reconcile orders.
* Prepare records of receipt for incoming materials and equipment in accordance with SOX requirements.
* Responsible for the accuracy of all shipping documents (bills of lading, computer entry and tracking, inventory records, receiving reports, stock location tags, returned goods records, etc.).
* Collect and disseminate information for claims on in-transit damaged materials.
* Inventory & Storage Management:
* Responsible for maintaining MannKind's Danbury Site as a Foreign Trade Zone (FTZ) according to USCBP rules and regulations
* Supervise internal transfer of materials and ensure appropriate procedures are in place to meet internal quality and financial compliance.
* Supervise warehousing of materials and assure all materials are stored in compliance with quality, environmental and safety procedures.
* Develop ways to increase capacity within space constraints.
* Quality & Compliance:
* Ensure compliance with cGMPs, SOX, FDA, FAA, ISO and OSHA regulations.
* Write and/or review SOPs, as needed.
* Represent Warehouse Operations in internal and external audits.
* General Operations & Safety:
* Responsible for observing all Company, Health, Safety and Environmental guidelines.
* All other functions within Warehouse Operations including special projects requested by Management.
Qualifications:
* BA/BS in a technical discipline with 7-10 years of experience in a regulated pharmaceutical environment or MS/MBA with 5-7 years related experience or an equivalent combination of training and related experience
* 7 years management experience, preferably in a cGMP warehouse environment
* Strong leadership, management, problem-solving, and organizational skills. Excellent attention to detail and communication skills.
* Deep expertise in cGMP, GDP, FDA, DSCSA, SOX, OSHA, and other relevant regulatory requirements for material handling and logistics. Experience presenting during audits/inspections is required.
* Experience with inventory management and control
* Knowledge of IATA, DOT shipping and HAZWOPER procedures
* The ability to effectively use PC software applications, such as MS Word, Excel, PowerPoint, Project, MRP applications etc.
* Ability to work independently with minimal supervision
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)