Quality Assurance Specialist

4 weeks ago

Geneva, Ohio, United States BioDerm Full time
Job Title: Quality Assurance Specialist

At BioDerm, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for overseeing and executing design and process validation activities to ensure regulatory compliance and high-quality production processes and products.

Key Responsibilities:

  • Maintains quality assurance objectives complementary to corporate policies and goals.
  • Participates in the Design and Development process.
  • Writes IQ, OQ, and PQ protocols for new and modified equipment and software.
  • Performs IQ, OQ, and PQ activities for new and modified equipment and software.
  • Writes IQ, OQ, and PQ reports.
  • Consistently meets project due dates.
  • Assists Engineering with process development and engineering trials.
  • Ability to write technical documentation clearly and informatively.
  • Participates in Corrective and Preventive Actions, Complaint Investigations, Non-Conformance investigations, and any required follow-up actions as it relates to validation activities.
  • Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
  • Maintains a working knowledge of company quality assurance documents, instructions, and procedures.
  • Plays an active role on quality management teams within the organization.
  • Assists in training personnel as it relates to validation activities.
  • Participates as a team member in process and product improvement activities as it relates to validation activities.

Requirements:

  • Experience in validation activities.
  • Technical degree (Certificate, AS, BS, or higher), preferably in technical writing or a scientific field.
  • Language Ability:
    • Ability to read and interpret quality assurance and company procedures.
    • Ability to communicate clearly and concisely, both verbally and in writing.
    • Ability to effectively present information and respond to questions from employees, supervisors, managers, and executive staff.
  • Math Ability:
    • Ability to apply concepts such as fractions, percentages, ratios, and proportions.
  • Reasoning Ability:
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to perform statistical analysis.
  • Computer Skills:
    • Familiarity with Microsoft Word, Excel, and Outlook or similar e-mail program.
    • Familiarity with using a statistical program such as MiniTab.
  • Certificates and Licenses:
    • No certifications required. ASQ certification preferred.
  • Supervisory Responsibilities:
    • This position has no supervisory requirements.
  • Attendance and Punctuality:
    • Is consistently at work and on time; ensures work responsibilities are covered when absent, arrives at meeting and appointments on time and prepared.
  • Dependability:
    • Follows instructions; responds to management direction; takes responsibilities for own actions; keeps commitments; completes tasks on time or notifies appropriate management.
  • Problem Solving:
    • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Interpersonal:
    • Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to other's ideas and tries new things.
  • Oral Communication:
    • Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
  • Written Communication:
    • Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively; Able to read and interpret written information.
  • Team Work:
    • Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.
  • Ethics:
    • Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
  • Organizational Support:
    • Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.
  • Adaptability:
    • Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Initiative:
    • Volunteers readily; Seeks increased responsibilities; Asks for and offers help when needed.
  • Innovation:
    • Generates suggestions for improving work;
  • Motivation:
    • Demonstrates persistence and overcomes obstacles.
  • Planning/Organizing:
    • Prioritizes and plans work activities; Uses time efficiently.
  • Professionalism:
    • Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
  • Quality:
    • Demonstrates accuracy and thoroughness in work performed; looks for ways to improve and promote quality; monitors work to ensure quality.
  • Quantity:
    • Meets productivity standards; completes work in a timely manner; strives to increase productivity; works quickly and efficiently.
  • Safety and Security:
    • Observes safety and security protocols; reports potentially unsafe conditions; uses equipment and materials properly.

Work Environment and Physical Demands:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Specific vision abilities required by this job include Close vision.

  • Sign Production Specialist

    3 weeks ago

    Geneva, Ohio, United States FastSigns Full time

    Key Responsibilities:As a Sign Production Specialist at FASTSIGNS, you will be responsible for following a layout to place computer-cut vinyl or full-color graphic images on a predetermined substrate or medium. You will also prepare substrates for vinyl application, including cutting, painting, laminating, cleaning, and weeding excess vinyl from computer-cut...

  • Route Delivery Specialist

    3 weeks ago

    Geneva, Ohio, United States Culligan 101IL Full time

    About the Role:Culligan 101IL is seeking a skilled Route Delivery Specialist to join our team. As a Route Delivery Specialist, you will be responsible for delivering water treatment products to homes and businesses in an efficient and timely manner.Key Responsibilities:Deliver water treatment products to customers in a safe and courteous manner.Prepare,...

  • Anesthesiology Specialist

    3 weeks ago

    Geneva, Ohio, United States Cameron Craig Group Full time

    Job Opportunity: We are seeking a skilled Certified Registered Nurse Anesthetist to join our team at the Cameron Craig Group. As an Anesthesiology Specialist, you will be responsible for providing high-quality patient care in a fast-paced environment. Key Responsibilities: • Provide anesthesia services to patients undergoing surgical procedures •...

  • Emergency Response Specialist

    4 weeks ago

    Geneva, Ohio, United States University Hospitals Full time

    Key ResponsibilitiesAs an Emergency Response Specialist at University Hospitals, you will assist patients and healthcare needs as directed by clinicians during Emergency Department visits. This includes performing 12-lead EKGs, blood draws, initiating Hep-locks, bedside point-of-care testing, and aerosol treatments. You will also ensure the daily completion...

  • Travel Physical Therapist

    3 weeks ago

    Geneva, Ohio, United States Aureus Medical Group - Therapy Full time

    Job Title: Travel Physical Therapist - Pelvic Floor SpecialistJob Summary:Aureus Medical Group - Therapy is seeking a skilled Physical Therapist to join our team for a travel job in Geneva, New York. As a Pelvic Floor Specialist, you will be responsible for providing high-quality care to patients with pelvic floor issues. This is a 19-week assignment with a...

  • Nurse Practitioner

    3 weeks ago

    Geneva, Ohio, United States Rochester Regional Health Full time

    Job SummaryAs a Nurse Practitioner at Rochester Regional Health, you will play a vital role in providing high-quality medical services to ambulatory patients. Your exceptional interpersonal and empathetic skills, combined with your expertise in diagnostic procedures, will enable you to deliver exceptional patient care.Key Responsibilities Diagnosis: Assess...

  • Pathologist Assistant II

    3 weeks ago

    Geneva, Ohio, United States Northwestern Memorial Healthcare Full time

    Job SummaryThe Pathologist Assistant II - Surgical Pathology Specialist will assist pathologists in the gross examination and dissection of surgical biopsies and large complicated specimens. This role requires a strong understanding of anatomical pathology and the ability to work independently in a fast-paced laboratory environment.ResponsibilitiesPerform...

  • Nurse Practitioner

    3 weeks ago

    Geneva, Ohio, United States Matrix Medical Network Full time

    About Us:Matrix Medical Network is a leading provider of clinical services and care management solutions. Our team of experienced clinicians works closely with primary care providers and at-risk health plan members to deliver high-quality, patient-centered care.We offer a range of clinical services, including home risk assessments, telehealth visits, and...

  • Medical Laboratory Technician/Technologist

    4 weeks ago

    Geneva, Ohio, United States Lighthouse Lab Services Full time

    Job OpportunityLighthouse Lab Services is seeking a part-time Medical Laboratory Technician/Technologist to join their team in Geneva, Ohio.About the Role:Perform high and moderate complexity testing with some supervision.Conduct laboratory support functions.Perform various testing in all departments, following quality assurance policies and...

  • Nurse Practitioner

    3 weeks ago

    Geneva, Ohio, United States CHS Recruiting Full time

    Job Summary:We are seeking a skilled Nurse Practitioner to join our team as a Hospitalist/Nocturnist. The ideal candidate will have experience in acute care and be able to provide high-quality patient care in a fast-paced environment.Responsibilities:- Provide continuous care to hospitalized patients- Order tests and medical procedures- Collaborate with care...

  • Intégrateur de données

    3 weeks ago

    Geneva, Ohio, United States IT Advanced Consulting SA Full time

    Mission principale du posteL'intégrateur de données a pour mission principale de réaliser des flux de données dans des contextes variés : reprise de données, mise en œuvre de flux comprenant plusieurs sources de données, intégration des règles métiers et création des indicateurs de qualité des données.L'intégrateur de données doit...

  • Manufacturing Specialist

    3 weeks ago

    Geneva, Ohio, United States General Mills Full time

    At General Mills, we manufacture some of the world\u2019s most beloved foods, including Cheerios, Lucky Charms, Nature Valley granola bars, Totino\u2019s pizza rolls, and Yoplait yogurt.As a Production Worker, you will be part of a team that ensures the highest quality products are delivered to our customers.Key responsibilities include:Working in a...

  • Industrial Coatings Specialist

    3 weeks ago

    Geneva, Ohio, United States HDT Global Full time

    At HDT Global, we're a leader in engineering, designing, and manufacturing of cutting-edge military expeditionary products and rugged industrial/commercial products since 1937.We offer a comprehensive benefits package, including health, dental, and vision coverage, as well as life, AD&D, and disability insurance, and a 401K plan with company match.The ideal...

  • Comprehensive Hospitalist Nurse Practitioner

    3 weeks ago

    Geneva, Ohio, United States Resiliency Full time

    Position Summary:At Resiliency, we are seeking a skilled Family Nurse Practitioner to provide exceptional care to hospitalized patients during nighttime shifts. This role involves managing patient care, performing assessments, and collaborating with other healthcare professionals to ensure optimal outcomes.Key Responsibilities:Provide direct patient care,...

  • Cardiology Specialist

    3 weeks ago

    Geneva, Ohio, United States She Recruits. LLC Full time

    Job Title:A renowned healthcare network in the Finger Lakes region is seeking a dedicated, full-time Non-Invasive Cardiologist to join its team serving two regional hospitals. This is a direct-hire position offering competitive compensation, comprehensive benefits, and the opportunity for a healthy work-life balance in the scenic Geneva and Penn Yan...

  • Travel Nurse Position

    4 weeks ago

    Geneva, Ohio, United States Emerald Health Services Full time

    Med/Surg RN Job OpportunityEmerald Health Services is seeking a skilled Travel RN - Med/Surg to join our team. This 13-week assignment offers a unique opportunity to work in a dynamic environment with a competitive compensation package.**Job Details:**Shift: Nights, 7p-7:30a, 12x3, 36hrs per weekLength: 13 weeks**Requirements:**OH License2 Years...

  • Medical Laboratory Specialist

    3 weeks ago

    Geneva, Ohio, United States K.A. Recruiting Full time

    Exciting Laboratory Opportunity AvailableLocated in Western New York, this hospital is the only full-service, acute care system in its county.Job Requirements:• Bachelor's Degree in Medical Technology or a related field• New York State Medical Technologist licenseThis is a full-time night shift position with a reputable hospital. If you are a motivated...

  • Practical Nurse Specialist

    3 weeks ago

    Geneva, Ohio, United States TotalMed Staffing Full time

    About the Role:This position involves providing high-quality patient care in a long-term care setting. As a Licensed Practical Nurse, you will be responsible for administering medications, monitoring patient conditions, and collaborating with other healthcare professionals to ensure the best possible outcomes.Key Responsibilities:• Administer medications...

  • Medical Laboratory Specialist

    3 weeks ago

    Geneva, Ohio, United States K.A. Recruiting Full time

    Exciting Laboratory Opportunity at a Top Western NY HospitalLocated in a scenic area less than an hour from Buffalo, NYFull-time position available on the night shiftThe hospital is the only full-service, acute care system in its countyKey Requirements Bachelor's Degree in Medical Technology or a related field New York State Medical Technologist licenseAs a...

  • Dietitian - Patient Care Specialist

    3 weeks ago

    Geneva, Ohio, United States Finger Lakes Health Full time

    POSITION SUMMARY:The Dietitian provides quality patient care in collaboration with the Nutrition Services Manager. He or she identifies patient needs and participates with the direct care team in the development and execution of the Multidisciplinary Care Plan. Compiles and evaluates data in preparing Nutritional Assessments and Care Planning in compliance...