Validation, Quality Assurance Specialist
Validation, Quality Assurance Specialist
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from K3-Innovations, Inc.
Job Title: Validation, Quality Assurance Specialist
Location: Northborough, MA 01532
Contract Term
Position Overview:
We are seeking a highly organized and detail-oriented Validation Study Binder Compliance Specialist to support External Manufacturing and Supply for Large Molecule Specialty Care (EM&S LM SC). The Specialist will ensure compliance with Good Documentation Practices (GDP) and Data Integrity standards through the review, digitization, and proper archiving of validation study binders. This role plays a critical part in maintaining GxP compliance across our contract manufacturing and testing network.
Key Responsibilities:
* Review identified validation study binders to assess adherence to Good Documentation Practices (GDP) and Data Integrity requirements.
* Document findings and observations using standardized formats provided by the team.
* Track and manage the status of each binder including:
* Number of binders reviewed
* Issues identified
* Binders digitized and uploaded
* Digitize and scan all reviewed binders according to specified protocols.
* Manage digital files with appropriate naming conventions and ensure successful integration into the electronic Quality Management System (eQMS) with accurate metadata and routing for approval.
* Support inventory tracking and labeling of physical and digital files.
* Coordinate and manage all requirements related to physical archiving preparation.
* Collaborate closely with relevant cross-functional teams to ensure documentation compliance and audit readiness.
Required Qualifications:
* Prior experience with Good Documentation Practices (GDP) and GxP compliance in a biopharmaceutical or manufacturing setting.
* Strong understanding of Data Integrity principles.
* Experience working with documentation management tools and electronic Quality Management Systems (eQMS).
* Detail-oriented with excellent organizational and record-keeping skills.
* Ability to manage large volumes of documentation and meet deadlines.
* Strong communication and coordination skills.
Preferred Qualifications:
* Experience in a regulated manufacturing or validation environment.
* Familiarity with archiving best practices and document lifecycle management.
This role is based onsite in Northborough, MA, within a highly collaborative and regulated environment. The position may require handling physical documentation and working with digitization equipment.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Science and Manufacturing
Referrals increase your chances of interviewing at K3-Innovations, Inc. by 2x
Sign in to set job alerts for “Quality Assurance Specialist” roles.
Manager, Quality Assurance (QA), Global QMS
Boston, MA $75,000.00-$95,000.00 3 months ago
Boston, MA $71,453.20-$102,351.00 1 month ago
QA Specialist II, Validation, Contractor
Canton, MA $70,000.00-$85,000.00 1 day ago
Associate Director, Quality Assurance Document Control Management
Bedford, MA $170,900.00-$211,200.00 3 days ago
Lowell, MA $105,000.00-$125,000.00 1 week ago
Associate Director, Analytical Quality Assurance
Bedford, MA $180,300.00-$222,700.00 3 days ago
Associate Director, Quality Assurance GMP Training Management
Bedford, MA $175,800.00-$217,100.00 2 weeks ago
Associate Director, Quality Assurance – Facilities Management
Bedford, MA $179,400.00-$221,700.00 1 week ago
Quality Assurance Manager - Food Processing
Greenville, NH $75,000.00-$90,000.00 2 weeks ago
North Kingstown, RI $120,000.00-$125,000.00 2 weeks ago
Cambridge, MA $67,151.00-$79,460.00 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr