Job Posting for Aseptic Process Specialist at BERKSHIRE STERILE MANUFACTURING LLC
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.
Able to qualify and remain qualified as an aseptic operator after on-the-job training
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
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
Sign up to receive alerts about other jobs that are on the Aseptic Process Specialist career path.
Click the checkbox next to the jobs that you are interested in.
Sign up to receive alerts about other jobs with skills like those required for the Aseptic Process Specialist.
Click the checkbox next to the jobs that you are interested in.