Overview
QA Document Coordinator Jobs in Durham – North Carolina – USA at Cambrex
Overview:
The QA Documentation Coordinator
I supports the assignedQuality Assuranceteam in numerous areas
including document archive management, data entry and trending, GxP documentation management
and general office support. Performs miscellaneous job-related duties as assigned and cross trains to be
able to back up other team members.
This role ensures that all QA documentation activities are in compliance with company SOPs, GMP/GLP
standards and client requirements. Ability to work within adynamicand fast paced environment.
Responsibilities:
Organize and inventory records in a manner that provides efficient and effective viewing and
retrieval including but not limited to: testing records, training records, and equipment records.
Provides general office support including but not limited to: scanning records, sending records toclients, filing hard copy records, reconciling records, retrieving records and archiving records.
Assigns controlled document numbers, as required.
Works with QA team to track trending data.
Updates and maintains GxP documentation in applicable software
Manage the logbook request forms, bind approved logbooks and distribute as needed
Support Quality project initiatives
Is the resource for all QA documentation support activities and may train others on processes asneeded.
May be asked to perform additional duties in assigned and unassigned areas.
Under manager supervision, able to comply with GMP, SOPs and basic regulatory guidance.
Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
Ability to participate in internal, client and/or regulatory audits.
Effectively coordinates and organizes tasks to help drive the activities of the department; while performing a variety of duties on schedule, with accuracy and competency.
Ability to take direction from others and contribute in ateam environment.
Qualifications /
Skills::
Detail-oriented, organized and applies effective time management skills in order to meet all deadlines.
Able to successfully prioritize and manage multiple tasks and numerous projects in afast-paced environment.
Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
Promote a safe environment for work.
Ability to document all work activities clearly and concisely in a timely manner utilizing existing forms and records. Writes legibly.
Communicate clearly and effectively both orally and in writing with internal and external clients.
Basic Understanding of current FDA and GMP / GLP regulations.
Basic knowledge of Master Control, Trackwise and/or other QMS software applications, preferred.
Perform basic math functions to include product accountability and material adjustment calculations and rounding
Skills / Abilities:
Ability to learn and apply GMP and SOP concepts during day-to-day processes.
Communicate clearly and effectively both orally and in writing with internal and external clients.
Ability to work across numerous scientific and management disciplines.
Good Computer Skills
Microsoft Suite, proficiency
Qualifications:
High school diploma required or AAS degree, preferred.
2+ years of office experience and/or regulated work experience.
#J-18808-Ljbffr
Title: QA Document Coordinator
Company: Cambrex
Location: Durham – North Carolina – USA
Category: Quality Assurance – QA/QC, Administrative/Clerical
