Quality Documentation Specialist
Scientific Search
Location: Malvern, PA Overview The Quality Documentation Specialist is responsible for reviewing and verifying documentation to ensure compliance with regulatory standards and internal quality control practices. The Quality Documentation Specialist will focus on maintaining accurate and organized record archives, conducting thorough reviews to ensure documentation is complete, accurate, and relevant, and supporting continuous improvement in documentation processes. Job Function: The Quality Documentation Specialist is responsible for ensuring all documentation meets regulatory standards, internal quality guidelines, and industry best practices. The Quality Documentation Specialist will also support internal and external audits by ensuring documentation is audit-ready and compliant. Additionally, the specialist identifies and corrects documentation deficiencies, develops and improves documentation processes, and provides training to staff on document control procedures. Collaboration with cross-functional teams is essential to align documentation with organizational goals and resolve issues efficiently. The Quality Documentation Specialist also generates reports on document status, compliance issues, and process improvements, tracking key metrics to support continuous quality improvement. Responsibilities Utilizes independent judgment to initiate customer communication, request, review, and approve documentation. *
- Has authority to make decisions on requesting and approving documents from suppliers as they pertain to food safety, quality, legality, or product authenticity. *
- Serves as backup to the Quality Specialist. *
- Reviews, approves, and prepares Certificates of Analysis (COAs) in accordance with customer and regulatory requirements. *
- Reformats and maintains specification packages as necessary to ensure consistency and accuracy.
- Fulfills customer document requests and uploads required documentation into customer systems (e.g., TraceGains, Safety Chain, or similar platforms). *
- Participates in mock recalls and traceability exercises as required. *
- Participates in department projects and process improvement initiatives; completes additional tasks as assigned.
- Entry level position
- Strong writing and organizational skills
- Attention to detail
- Proficiency in research and technical understanding
- Effective communication abilities
- Adaptability to industry changes,
- Basic project management skills
- A knack for problem-solving.
- Intermediate computer skills required, with demonstrated proficiency in Microsoft Excel (e.g., data tracking, basic formulas, and reporting) and Microsoft Office Suite (Word, Outlook, PowerPoint).
- Bachelor’s degree preferred
Vacancy posted 20 hours ago
Similar jobs that could be interesting for youBased on the Quality Documentation Specialist in Malvern, PA vacancy
- ...Job Title: Quality Documentation Specialist Location : Exton, PA (Fully Onsite) Department: Quality Schedule : Full-Time | Monday–Friday, 8:30 AM – 5:00 PM (occasional overtime) Reports To: Quality Assurance Manager Who We Are The Food Source International...SuggestedFull timeWork experience placementWork at officeMonday to Friday
The Food Source International, Inc.
Exton, PA2 days ago - The Food Source International, Inc. seeks a Quality Documentation Specialist in Exton, PA. This full-time role involves maintaining documentation accuracy and compliance with regulations. Key tasks include supporting audits and document management while collaborating with...SuggestedFull time
- ...Quality Systems Specialist Responsibilities: Supporting core Quality Systems activities (SOP revisions, inspection readiness, metrics... ...background in cGMP environments. ~ Experience with SOPs, document control, quality metrics, and electronic quality systems....Suggested
Katalyst HealthCares & Life Sciences
Exton, PA20 hours ago - ...delivering life‑saving injectable medicines. Job Summary As a Quality Assurance Specialist at West Analytical Lab Services, you will provide quality... ...approving investigations, corrective actions, validation documents, and change control documentation; driving initiatives to...SuggestedWork experience placementWork at officeRelocation3 days per week
$40 per hour
Piper Companies is currently looking for an experienced Quality Control PCR Specialist in Exton, Pennsylvania (PA) to work for a pharmaceutical cell therapy company. Responsibilities for the Quality Control PCR Specialist include: Utilize skills with PCR, HPLC (Empower...Suggested- A national recruiting company is seeking a Document Control professional for a contract position in Exton, PA. The role consists of entering data into databases, managing document uploads, and conducting database searches. This position requires strong organizational skills...Contract work
- Product Quality Surveillance Senior Specialist - Commercial Complaints Contract Integrated Resources, Inc., is led by a seasoned team with combined... ...or assist in the review of SOPs, and other Client cGMP documentation including but not limited to CAPA, Deviation, etc)...Contract workWork at officeLocal areaHome office
- ...midterm changes in an accurate and timely manner. The UA must understand and effectively utilize internal corporate systems, and provide quality service to both internal and external customers. What will your essential responsibilities include? Perform tasks to...Work at officeFlexible hours
AXA
Exton, PA20 hours ago $65k - $85k
...proficiency in Microsoft Office, and strong organizational skills. Responsibilities include administrative support to inspection teams, documentation management, and general office coordination. The position offers an annual salary between $65,000 and $85,000, along with...Work at office$40 - $45 per hour
Alphanumeric Systems is hiring a Compliance Specialist - Level 2 in Collegeville, Pennsylvania. This role involves supporting documentation lifecycle management and compliance within a regulated environment, with responsibilities including documentation reviews, version...Hourly pay$40 - $45 per hour
Alphanumeric Systems Inc is seeking a Compliance Specialist - Level 2 in Collegeville, Pennsylvania. This role focuses on supporting documentation lifecycle management, compliance, and audit readiness within a regulated environment. The ideal candidate holds a Bachelor'...Hourly pay- ...the Commercial Bond team. This role involves supporting underwriting activities, collaborating with underwriters, and maintaining documentation and reports. The ideal candidate will have a Bachelor's degree, 2-4 years of insurance experience, and strong communication and...
$60.6k - $86.2k
A global insurance firm is seeking a proactive Underwriting Assistant to support the Commercial Bond team in Exton, PA. The candidate will aid in underwriting processes, ensure accurate account management, and generate reports. A Bachelor's degree and 2-4 years of relevant...$60.6k - $86.2k
Underwriting Assistant - Commercial Bond, PRCB Specialty Lines Exton, PA, UA Chicago, IL US The Political Risk, Credit and Bond (PRCB) Unit at AXA XL provides top‑tier underwriting solutions, valuable risk engineering, and global claims capabilities for Political Risk...Work at officeWorldwide$20 - $23 per hour
...practice and retain clinical autonomy. All Heartland Dental supported doctors are united by a common goal: delivering the highest quality dental care and experiences to the communities they serve. At Heartland Dental, we're committed to living our core values which...Daily paidFull timeWork at officeLocal areaBartram Family Dental Care
Exton, PA1 day ago- ...Information High school diploma or general education degree (GED) and/or one year related experience and/or training in manufacturing quality; or equivalent combination of education and experience Ability to add, subtract, multiply, and divide in all units of measure,...Day shift
IDEMIA
Exton, PA4 days ago - ...badge systems Maintain knowledge of Paychex Flex; serve as payroll backup Track OSHA and Workers' Compensation claims and documentation Manage 889 compliance forms Benefits & Insurance Coordination Serve as liaison to Alera Group (Workers Comp Claims...Work at officeLocal areaFlexible hours
The O'Connor Group
Exton, PA4 days ago - ...RESPONSIBILITIES Direct the flow of all files and paperwork to and from the file room. Accurately catalogue all court documents and files using CPSMS and the RFID tracking system Check-out and return all files quickly and efficiently along with locating...Work at officeImmediate start
Montgomery County Pennsylvania
Norristown, PA2 days ago - ...equipment, and kitchen inventory Receive and distribute mail and deliveries Administrative Support Draft, proofread, and format documents such as letters, memos, reports, and meeting notes Schedule meetings, appointments, and conference calls for team members...Work at office
- ...Administrator to provide comprehensive administrative support. This role involves managing day-to-day office operations, organizing documentation, and ensuring a professional work environment. Ideal candidates should possess strong organizational skills, have over two years...Work at office
- ...with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team... ...The primary function will be to manage and organize all quality documentation that is required by Globus Medical, Inc. and other regulatory...Work experience placement
Globus Medical
Norristown, PA2 days ago $16.47 per hour
...missing issues Shelves books, straightens, and reads shelves periodically, shifts material on shelves as necessary Types library documents, correspondence, and other word processing duties as assigned Answers telephone requests Assists patrons in use of library media resources...Hourly payWork at officeLocal areaImmediate startMonday to FridayShift workDowningtown Area School District
Exton, PA4 days ago- ...Job Description Job Description Job Title: Quality Systems Specialist Position Type: Full Time Job Description Number: JD65 Revision... ...effective, and efficient operations. Maintain controlled documents and records, support internal/external audits, and...Full timeWork at office
Burlington Medical
Norristown, PA7 days ago $18.07 per hour
...conversation. Iron Mountain is seeking a motivated Data Entry/Document Specialist to join our Operations team in Royersford, PA. In this role,... ...be responsible for ensuring the secure, accurate, and high-quality conversion of physical documents into digital assets,...Permanent employmentFull timeRemote workMonday to FridayNight shiftDay shiftAfternoon shiftIron Mountain Inc
Royersford, PA4 days ago$18.07 per hour
...conversation. Iron Mountain is seeking a motivated Data Entry/Document Specialist to join our Operations team in Royersford, PA. In this role,... ...be responsible for ensuring the secure, accurate, and high-quality conversion of physical documents into digital assets,...Permanent employmentTemporary workPart timeRemote workWeekend workAfternoon shiftIron Mountain Inc
Royersford, PA4 days ago- ...Role Overview: The Quality Performance Specialist - Clinical supports the Quality Management (QM) team by leading and coordinating clinical quality reviews of member concerns and medical records, ensuring adherence to established standards of care. This role plays a...Contract workWork at officeRemote work
AmeriHealth Caritas
Newtown Square, PA4 days ago - ...inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality... ...Description Client: Direct Client Job Title: Quality Compliance Specialist III Location: Wayne, PA Duration: 7 Months + (Possible...Contract workLocal areaHome office
- ...pharmaceutical company in Exton, Pennsylvania, is seeking a Quality Assurance Specialist to oversee compliance with regulatory standards and... ...You'll be responsible for assessing lab work, managing documentation, and ensuring quality systems operate effectively. The ideal...Relocation3 days per week
- West Pharmaceutical Services, Inc is hiring for a Quality Specialist to provide quality assurance support at their Exton site. This hybrid role requires on-site presence at least 3 days a week. Responsibilities include ensuring compliance with cGMP and ISO standards, reviewing...3 days per week
- Diamond Manufacturing Company is seeking a detail-oriented Nuclear Quality Assurance Representative for our Exton, PA location. This role... ...promoting quality standards while reviewing technical documentation related to customer Purchase Orders and supplier compliance. The...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Documentation Specialist. Be the first to apply!
Related searches