Documentation Specialist

Mindlance; Branchburg Township (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Mindlance is seeking a Change Control Manager to supervise the development, creation, and revision of controlled documentation in compliance with GMP, 21CFR820, ISO 13485 and AATB standards. Establish partnerships with Managers and supervisors across local and global functions.

Work with Change Control, Quality Investigations/CAPA teams and other cross-functional managers to ensure accurate information per specifications. Serves as primary contact for change initiators and guides the process.

Qualifications

• Bachelor’s degree or 5–7 years equivalent experience.
• 3–5 years’ experience in a technical writing position within pharma/medical device/biotech.
• In-depth knowledge of MS Word including tables, headers/footers, and review.
• Familiarity with EDMS (One Vault) and ERP System (SAP).
• Project management capabilities.
• Strong writing, proofreading, and editing skills.
• Understanding of FDA, GXP, 21CFR820, ISO 13485 and AATB standards.

Responsibilities

• Supervise development, creation, and revision of controlled documentation per policies and standards.
• Collaborate with cross-functional teams across local and global functions.
• Serve as primary contact for change initiators and guide the process.
• Act as SME for document creation, formatting, and EDMS use.
• Support 5S and maintain a safe, pleasant work environment.
• Lead in absence of Change Control Manager and mentor team members.
• Represent Documentation and Change Control during regulatory audits.
• Process controlled documentation in EDMS per procedures.
• Review change requests and ensure timely closure.

Skills

Technical Writing

Change Management

Records Management

Communication

Education

Bachelor’s degree

Tools

MS Word

EDMS (One Vault)

SAP ERP

MS Office Suite

Job description

Duration-End of the year with possible extension

Top 3 – 5 Skills Needed for each role

• Technical Writing
• Change Management
• Records Management

100% ONSITE ROLE

JOB SUMMARY:

Supervise the development, creation, and revision of controlled documentation in accordance with *** policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. Establish partnerships with Managers and supervisors throughout local and global functions. Work with Change Control, Quality Investigations /CAPA team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information/parameters per process/product specifications. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues with minimal supervision. Serves as a representative for Quality Documentation and Change Control during regulatory audits. Fulfill the responsibilities and tasks of the Change Control Manager in their absence as well as be a team lead and provide guidance and direction to other team members.

IMPORTANCE

Author changes to controlled documentation, including but not limited to standard operating procedures, work instructions, batch records and forms.

Act as Initiator for Change Controls. Work with complex tasks and tight deadlines. Responsible for the execution of all steps to ensure timely completion of changes.

Act as subject matter expert in document creation, format and alteration as well as EDMS use. Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity.

Active member in cross-functional collaborative efforts, attends huddles, team meetings. Participates in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Process Development, Quality, and other subject-matter experts to develop document content.

Supports 5S methodology and ensures the area is safe and pleasant working environment.

Processes controlled documentation in the EDMS (Electronic Documentation Management System) in accordance with policies and procedures.

Reviews and evaluates change requests of varying complexity with minimal supervision.

Evaluates objective data associated with various change requests and follows up on activities required for closure.

Collaborate with internal and external customers.

Develop and implement process improvements regarding electronic document management system methods and provide training to support staff accordingly.

Represent Documentation and Change Control during regulatory audits

Communicates with management on a routine basis and escalates issues as needed.

JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

Bachelor’s degree, or 5-7 years equivalent experience.

3-5 years’ experience in a technical writing position within a pharmaceutical, medical device or biotech company.

In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.

In-depth knowledge of EDMS (One Vault) and ERP System (SAP).

Project Management capabilities.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

In depth knowledge of document authoring tools, including MS Office Suite.

Demonstrated ability in proofreading and editing.

Ability to multi-task and adjust to shifting priorities.

Strong interpersonal skills including the ability to effectively work and actively communicate with people and cross-functional teams.

Excellent oral and written communication skills as well as strong organizational skills.

Strong analytical skills, with an eagerness to work hard and achieve exemplary results.

Expert grammatical competency and writing skills.

Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.

Able to work professionally and courteously within a team environment sharing roles and responsibilities.

Ability to provide training and guidance to initiators of change requests.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”