Document Control Specialist
2 weeks ago
Spring Point Project is committed to improving the lives of people with Type 1 diabetes by providing a virtually unlimited supply of medical-grade, high-health pigs to serve as safe islet cell donors to people with diabetes.
We envision a world without diabetes, a world where monitoring and daily insulin injections are no longer a part of anyone's life.
------------------------------------------------------------------------------------------------------------------------
Position Title Document Control Specialist
Position Objective The Document Control Specialist reports directly to the Director of Quality. The Document Control Specialist supports quality assurance activities by reviewing records and documents for accuracy, completeness, and adherence to Spring Point Project quality management system, customer requirements, and cGMP and cGDP regulatory requirements.
The Document Control Specialist performs document management, tracking, and administrative support tasks for controlled document record systems as well as other tasks to assure the schedules and goals of the quality system are met.
Status Non-exempt
Accountable to Director of Quality
------------------------------------------------------------------------------------------------------------------------
Key Responsibilities and Duties
- Responsible for overall Quality Assurance (QA) document control coordination and functions, including document logs, tracking, processing, review, distribution, release, scanning, and archiving of documents per applicable SOPs and regulations
- Coordinate the revision, review, and approval and retirement of controlled documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), batch records, and worksheets
- Responsible for ensuring biennial review and continuous improvement review of all controlled documents
- Maintain SOP binders, paper-based logs, and controlled notebooks
- Organize and ensure accurate and reliable filing systems for all paper-based and computer-based GxP documents
- Maintain training records and ensure timely completion of scheduled training. Maintain change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents
- Maintain equipment records and other paper-based quality records
- This job description is representative of the types of duties and responsibilities that will be required of positions given this title and should not be construed as a declaration of the sole duties and responsibilities of any particular position. Employees may be directed to perform additional job-related tasks other than those specifically presented in this description
Qualifications and Experience
- Quality professional with a minimum of 1-3 years of experience performing document management in a regulated pharmaceutical or medical device industry with document control experience
- Demonstrated knowledge of ISO and FDA/Quality Systems such as cGMPs, 21 CFR 210, 211, 11, and 820 and other regulatory agency requirements sufficient to apply to quality operations and compliance
- Must be proficient in the use of computers and Microsoft 365 applications such as Word, Excel, PowerPoint, and additionally Adobe Acrobat. eQMS and/or Monday.com experience a plus
- Must be extremely well-organized with strong communication skills both verbal and written
- Ability to work independently or on teams
- Can maintain attention to detail while executing multiple tasks
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks to meet deadlines
- Ability to effectively build and maintain interdepartmental communication and relationships both in-person and hybrid
- Audit or inspection experience a plus
- Project management experience a plus
Education:
- Bachelor’s or Associate degree in a related skill (Preferred)
-
Document Control Specialist
2 weeks ago
New Richmond, United States Spring Point Project Full timeSpring Point Project is committed to improving the lives of people with Type 1 diabetes by providing a virtually unlimited supply of medical-grade, high-health pigs to serve as safe islet cell donors to people with diabetes.We envision a world without diabetes, a world where monitoring and daily insulin injections are no longer a part of anyone's...
-
Document Control Specialist
2 days ago
New Brunswick, United States K&A Engineering Consulting PC Full timeHeader: K&A Engineering Consulting White Plains, NY is a people-first organization. We value knowledge and learning. We believe in the power of connection, and collaboration, and we seek to build relationships that mean something. We employ some of the best and brightest in the industry and we work hard to maintain a culture that our people can be proud of....
-
Document Care Specialist
3 weeks ago
New City, United States CASO Document Management Full time**Attention, all aspiring heroes! We're on the lookout for extraordinary individuals to join our exceptional squad. Only applicants who complete the typing assessment included in this job posting will be summoned for a heroic interview.** **Key Superhero Requirements**: - Schedule - Monday-Thursday (9:00 am - 5:00 pm) - Lightning-fast typing speed of at...
-
Document Quality Control Specialist
2 weeks ago
New Bedford, Massachusetts, United States Adecco Staffing, USA Full timeA Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. This position will report to the Sr. Manager, QC and Sample Management. Note that this...
-
Document Control Specialist
2 weeks ago
New York, United States Conflux Systems Full timeJob title: Quality Documentation Administrator Pay rate : $32.29 Location: MA - Newton - 275, Grove Street (NTN GR) Description: Responsibilities: • Disposition non-conforming material (NCMR). • Lead and/or participate in product complaint investigations leading to root cause. • Propose, lead, initiate and follow-up on Corrective Action and Preventive...
-
Document Review Specialists
2 weeks ago
Richmond, United States Bluebird Technologies Inc. Full timeJob Title: Document Review SpecialistsDuration: 12+ Months (With possible extension)Location: Richmond, VA (Onsite) RESPONSIBILITIES:We are seeking detail-oriented Document Review Specialists to assist in evaluating a large volume of electronic documents. The ideal candidates will be responsible for reviewing documents to determine drafts or early versions...
-
Document Control Coordinator
1 week ago
New Rochelle, United States Atlas Technical Consultants Full timeAtlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in Austin, TX, Atlas currently has over 3,500 employees in offices throughout the US. It's no accident that Atlas creates a better experience for infrastructure and...
-
Document Control Clerk
5 days ago
New Brunswick, United States Datawize Technologies LLC Full time**Work Hours: 8:30-4:30** **Lunch hours(unpaid): 1 Hour** **Dress Code: Business casual** **Office or Remote: office** **location: 550 Jersey Ave. New Brunswick 08801** **Parking: Parking available next to office** **Job Description: - ** Equipment to be used by the temporary staffing professional(s): Computer, phone, postage machine, copier 2....
-
Documentation Specialist
1 month ago
Richmond, United States Pomeroy Technologies, LLC. Full timeJob DescriptionJob DescriptionOur client is seeking a highly motivated and detail-oriented Documentation Specialist to join their dynamic team. This role is pivotal in converting hard copy documents into digital formats and enhancing the digitization processes. The ideal candidate will have a proven track record in document management and digitization, and...
-
Document Review Specialist
3 weeks ago
Richmond, United States IMS People Full timeJob DescriptionJob DescriptionDocument Review SpecialistJob DescriptionWe are seeking detail-oriented Document Review Specialists to assist in evaluating a large volume of electronic documents. The ideal candidates will be responsible for reviewing documents to determine drafts or early versions vs. final documents for possible purging. Review of content...
-
Document Review Specialist
1 week ago
Richmond, United States Crescens Full timeTitle: Document Review Specialist Location: Richmond VA Duration: 12+ Months Type: ContractDescription We are seeking detail-oriented Document Review Specialists to assist in evaluating a large volume of electronic documents. The ideal candidates will be responsible for reviewing documents to determine drafts or early versions vs. final documents for...
-
Document Review Specialist
3 weeks ago
Richmond, United States Crescens Full timeTitle: Document Review Specialist Location: Richmond VA Duration: 12+ Months Type: ContractDescription We are seeking detail-oriented Document Review Specialists to assist in evaluating a large volume of electronic documents. The ideal candidates will be responsible for reviewing documents to determine drafts or early versions vs. final documents for...
-
Documentation Specialist
3 weeks ago
New York, United States Calculated Hire Full timeHybrid – New York, NY9-month Contract (W2), Weekly Pay (40 hours/week)Desired Start Date: 5/22/2024Calculated Hire is in search of a Senior Documentation Specialist for our Fortune 100 Financial Services company. This team is responsible for the facilitation and maintenance of Markets Division supervisory procedures, control documentation, job aides, and...
-
Document Control Clerk
4 days ago
New Brunswick, United States Biogensys Full timeJob DescriptionJob DescriptionWe are hiring a Document Control Clerk / Filing Specialist for one of our clients in New Brunswick, NJ. Job Description:Filing, copying, collating, phonesSkills required:Pleasant, able to deal with difficult consumersTyping, filing,Education:H.S. DiplomaWork hours:8:30-4:30Lunch hours (unpaid): 1 HourAdditional information:Dress...
-
Final Documents Specialist
3 weeks ago
Richmond, United States JG Wentworth Full timeHeadquartered in the Washington, D.C. suburb of Woodbridge, VA., and licensed to operate in 40 states, J.G. Wentworth Home Lending (JGWHL) has built its success over the past 15 years in originating Conventional, VA, and FHA loans. Known for its outstanding reputation and commitment to excellence, JGWHL has earned several prestigious awards, including Costco...
-
Document Controls Analyst
2 weeks ago
New York, United States EXP Full timeJob Description At EXP, we're driven to provide innovative solutions for the world's built and natural environments. As a team of engineers, architects, designers, scientists, creators and a community of professionals, we bring diverse and talented people together to solve the world's most complex challenges. Here, you join a team that leverages differences,...
-
Document Controls Analyst
1 week ago
New York, United States EXP Full timeJob Description At EXP, we're driven to provide innovative solutions for the world's built and natural environments. As a team of engineers, architects, designers, scientists, creators and a community of professionals, we bring diverse and talented people together to solve the world's most complex challenges. Here, you join a team that leverages differences,...
-
Document Review Specialist
2 weeks ago
Richmond, United States CapLeo Global Full timeJob Title: Document Review Specialist Location: Richmond, VA 23219 (Hybrid) Duration: 12 Months Contract (With a High Possible Extension)Job Description: Review and assess electronic documents against guidelines Identify final documents requiring retention and ensure proper classification. Maintain accurate records of document assessments and decisions....
-
Document Review Specialist
3 weeks ago
Richmond, United States Global Pharma Tek Full timeJob Title: Document Review Specialist Location: Richmond, VA 23219 (Hybrid) Duration: 12 Months Contract (With a High Possible Extension)Job Description: Review and assess electronic documents against guidelines Identify final documents requiring retention and ensure proper classification. Maintain accurate records of document assessments and decisions....
-
Document Controller
6 days ago
New York, New York, United States Mace Full timePosition Status: This opportunity is for a secured role that is due to commence in March subject to approval. If you would like to be considered as we progress with this position, please click to apply.At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our...