Documentation Specialist jobs in Pittsfield, MA

Position Summary

The Manufacturing Aseptic Process Specialist is a hands-on role responsible for reviewing, creating and revising, and coordinating aseptic process qualifications specifically within the Manufacturing department.

These include media fill batch records, reports, and SOPs. The incumbent may also be responsible for the review and approval of client cGMP batch records that are not media fill specific.

Duties and Responsibilities

• Create / revise media fill master documents including batch records, reports, and SOPs.
• Collaborate with MFG, PE and PM groups on new and existing client dedicated media fill projects and timelines.
• Track due dates for media fill re-qualifications and proactively manage the revision and review of the necessary batch records to ensure all documents are approved on time.
• Through the QMS, initiate and drive MOCs and DCRs for media fill batch record creation and / or revision.
• Perform Master Document review including batch records, SOPs, protocols, etc.
• Manage the timely review of pre-executed batch records against cGMP requirements as well as assist in responding to batch record queries from internal / external sources
• Assist with implementation and supporting on-going continuous improvements of batch record creation and revision.
• Attend and complete all mandatory training.
• Other duties as assigned

Regulatory Responsibilities

• Conduct business in a responsible manner that complies with all state, OSHA and Federal regulations
• Demonstrate BSM values and behaviors at all times

Supervisory Responsibilities

N / A

Experience

• One (1) year of relevant post-degree work experience in a laboratory, manufacturing or quality position
• One (1) year of experience working in a position that complies with 21 CFR Part 210 / 211.

Education

• Associates degree preferred
• An equivalent combination of education and experience may be considered

Knowledge, Skills & Abilities

• Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
• Good understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Excellent technical writing skills
• Time management
• Attention to detail while executing multiple tasks
• Well-organized
• Good communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills

Physical Requirements

• Satisfactory audio-visual acuity
• Ability to sit for prolonged periods of time
• Ability to stand for prolong periods of time
• Able to lift up to 10lbs

Last updated : 2024-05-10