QA Document Coordinator

6 months ago

Durham, United States Cambrex Corporation Full time

Job Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.


Job Overview

The QA Documentation CoordinatorI supports the assigned Quality Assurance team 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 a dynamic and 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 a team 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 a fast-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 MasterControl, 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
Education, Experience & Licensing Requirements

High school diploma required or AAS degree, preferred. 2+ years of office experience and/or regulated work experience.

Supervision Received: General Supervision Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: Not Applicable

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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