Quality Assurance Specialist

2 weeks ago


Hyattsville, United States PN Automation, Inc. Full time

**This position is responsible for ensuring the document quality controls are enforced in support of the Food and Drug Administration (FDA). The primary functions of the Quality Assurance Specialists (QAS) is to perform 100% quality control checks for data entry and/or editor teams and ensure correctness, document control/processing, and the overall quality of deliverables within the scope of the work requirements. In addition, the QAS will function as a vocabulary specialist, having knowledge of and experience with medical devices and device terminology in a commercial environment or in a health information processing environment. While the QAS may be assigned to perform the functions above, they will also be cross trained to perform secondary duties according to project business needs.**

**Essential Duties and Responsibilities**
- Perform quality control of the data entry and editors to ensure correctness, document control & processing, and the overall quality of deliverables within the scope of the work requirements.
- Create and update excel spreadsheets to record the resolved problem reports.
- Process paper and electronic documents in accordance with current SOPs, as FDA moves into a electronic paperless environment.
- Redact patient and/or manufacturer confidential data.
- Make necessary changes to the work process, when requested.
- Provides quality control by reviewing completed work projects to ensure data accuracy, completeness, and timeliness.
- Function as a medical vocabulary specialist.

**Work Conditions**:

- Work is primarily performed within a hybrid work environment with some work performed onsite and some telework.

**Skills and Abilities Required**
- Technical background with knowledge of folder structure systems for electronic documents.
- Must have a combination of excellent analytical skills and a high attention to detail.
- Possess excellent verbal and written communication skills.
- Must be able to work in a fast-paced electronic production environment.
- Must have experience with reading and classifying scientific regulatory documents.
- Must have experience and working knowledge of the FOIA and redaction process.
- Must possess excellent customer service skills.
- Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
- Must possess excellent computer skills and experience with the querying and use of databases.

Minimum Education and Experience Required
- **Bachelor’s Degree, preferably in health or science related field AND/OR experience demonstrating an ability to use medical device terminology, understanding off policy issues, and experience in performing editing of documents.**:

- **Three (3) years related experience with two (2) years direct experience processing documents and at least one (1) year of office, records, or computer experience.**:

- **Must have knowledge and experience with medical devices and medical device terminology.**:

- **Ability to type 40 words per minute with no more than two errors.**

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance

Experience level:

- 3 years

Schedule:

- Monday to Friday

Work setting:

- In-person
- Office

**Experience**:

- Document processing: 3 years (required)

Ability to Commute:

- Hyattsville, MD 20785 (required)

Ability to Relocate:

- Hyattsville, MD 20785: Relocate before starting work (required)

Work Location: In person



  • Hyattsville, United States Apex Systems Full time

    Apex Systems has an immediate opening for a excellent entry-level career opportunity for recent graduates in the Food Science, Food, & Beverage or Engineering discipline to get their “foot in the door” with a great local company! Internship experience within food manufacturing/QA, GMP regulated environments supporting Quality, Food Safety or...


  • Hyattsville, United States Apex Systems Full time

    Apex Systems has an immediate opening for a excellent entry-level career opportunity for recent graduates in the Food Science, Food, & Beverage or Engineering discipline to get their “foot in the door” with a great local company! Internship experience within food manufacturing/QA, GMP regulated environments supporting Quality, Food Safety or...


  • Hyattsville, United States Apex Systems Full time

    Apex Systems has an immediate opening for a excellent entry-level career opportunity for recent graduates in the Food Science, Food, & Beverage or Engineering discipline to get their “foot in the door” with a great local company! Internship experience within food manufacturing/QA, GMP regulated environments supporting Quality, Food Safety or...


  • Hyattsville, United States Octapharma Full time

    Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company,...


  • Hyattsville, United States Chesapeake Home Health Care Full time

    Job DescriptionJob DescriptionJoin Chesapeake Home Healthcare, winner of the Best of Home Care Employer of Choice award for two consecutive years, in a fulfilling career that utilizes your passion for healing and your clinical expertise as our Quality Assurance RN!Become a part of a dedicated clinical team that strives to live up to our core purpose in all...


  • Hyattsville, United States Vidoori Full time

    Job DescriptionJob DescriptionTitleQuality Management SpecialistDescriptionVidoori, Inc., a rapidly growing small business that specializes in building strong Engineering teams that provide high quality, modern technical solutions to our clients is seeking a Quality Management Assistant who will: Assists in managing operational efficiencies, schedule...


  • Hyattsville, United States PCI Government Services LLC Full time

    Duties and Responsibilities The Mid-Level Contract Specialist shall provide advice, recommendations, and document support to multiple offices in all areas of the acquisition requirements phase. Mid-Level Contract Specialist support personnel shall coordinate with the Contracting Officer Representative (COR) on all requirement support services to include...


  • Hyattsville, United States PCI Government Services LLC Full time

    Duties and Responsibilities The Mid-Level Contract Specialist shall provide advice, recommendations, and document support to multiple offices in all areas of the acquisition requirements phase. Mid-Level Contract Specialist support personnel shall coordinate with the Contracting Officer Representative (COR) on all requirement support services to include...


  • Hyattsville, United States Synergy Family Services Full time

    Job DescriptionJob Description EDUCATION: Licensed mental health professional, (LMSW,LCSW,LGPC,LCPC or CPRP) Rehabilitation Counselor certified by the Commission on Rehabilitation Certification or Bachelor’s prepared certified psychiatric rehabilitation practitioner certified by the U.S. Psychiatric Rehabilitation AssociationDUTIES AND...


  • Hyattsville, United States Synergy Family Services Full time

    **Title**: PRP Rehabilitation Specialist/PRP Administrative Specialist** **Program**:Psychiatric Rehabilitation Program **Reports to**:PRP Program Director **Hours**:40 hours per week **QUALIFICATION CRITERIA**: **EDUCATION**:Licensed mental health professional, (LMSW,LCSW,LGPC,LCPC or CPRP) Rehabilitation Counselor certified by the Commission on...


  • Hyattsville, United States Your Wellness Sources Full time

    Your Wellness Sources is looking for a qualified Clinical Nurse Specialist. Your Wellness Sources provides Integrated Wellness Services that include primary care, nutritional counseling, women wellness exams, behavioral health services, addiction management or substance abuse treatment to culturally diverse populations. The Clinical Nurse will be part of our...


  • Hyattsville, United States Centrics Healthcare Services Full time

    Job DescriptionJob DescriptionSupported Employment Specialist (SES)We are seeking an Employment Specialist to join our team! This role will coordinate supported employment services to clients who need ongoing support to perform in a work setting and for individuals who may become virtually independent in the job setting over time. Services include continued...


  • Hyattsville, United States Your Wellness Sources Full time

    Job DescriptionJob DescriptionSalary: Your Wellness Sources is looking for a qualified Clinical Nurse Specialist. Your Wellness Sources provides Integrated Wellness Services that include primary care, nutritional counseling, women wellness exams, behavioral health services, addiction management or substance abuse treatment to culturally diverse populations....


  • Hyattsville, United States Advantage Solutions Full time

    Dedicated Retail Sales Specialist Indeed Job Description Job description Full Time Retail Sales Specialist What We Offer: - Full Time Benefits (Medical, Dental, Vision, Life). - 401(K) with company match. - Generous Paid Time Off. - Paid training and ongoing career development. - Mileage reimbursement. What You’ll Do: - Flex your organizational...


  • Hyattsville, United States Kaiser Permanente Full time

    Job Summary: Requests and reviews primary source information and verifications, with regular review from manager. Identifies and plans for resolution of standard and nonstandard gaps in vendor relationships and escalates, as needed. Serves as a main point of contact for external queries regarding practitioner status. Evaluates applications and supporting...


  • Hyattsville, United States CMT Services Inc Full time

    Job DescriptionJob DescriptionSalary: CMT Services is recruiting for a Talent Support Specialist/ Project Coordinator. PLEASE NOTE: THIS IS NOT A REMOTE / HYBRID POSITIONDisclaimer: By submitting your resume for this job posting, you authorize CMT Services, Inc. to forward your resume to all applicable internal and external managers, agencies, and...


  • Hyattsville, United States Interdynamics Inc Full time

    **Who We Are** Interdynamics delivers a variety of mental health services to clients across the lifespan-from pediatric and school-based services, to addiction and substance use counseling, to individual behavioral health services, and much more. At Interdynamics Inc., we are client-focused, value-oriented, quality-obsessed, and people-centric. By joining...

  • RN Clinical Mentor

    3 weeks ago


    Hyattsville, Maryland, United States MEDSTAR HEALTH Full time

    Acts as a mentor responsible for guiding the field training experience for newly hired and current clinicians. Mentors new hires throughout the first year of employment with the goal of improving clinical associate engagement and retention. Offers guidance and education to current field staff in clinical decision making. Performs patient care and case...


  • Hyattsville, United States Martin's Caterers Full time

    Regular Full-Time Cranbury, NJ-CDC, Cranbury, NJ, US 10 days ago Requisition ID: 2885 Salary Range: Job Description: US Electrical Services Inc., a leading electrical supplies distributor, is seeking an experienced and motivated Continuous Improvement Specialist with a focus on warehousing operations. This role is critical in supporting our ongoing efforts...

  • RN Clinical Mentor

    5 days ago


    Hyattsville, United States MedStar Health Full time

    General Summary of Position Acts as a mentor responsible for guiding the field training experience for newly hired and current clinicians. Mentors new hires throughout the first year of employment with the goal of improving clinical associate engagement and retention. Offers guidance and education to current field staff in clinical decision making....