Job Description
Documentation Coordinator IV, Manufacturing
About This Role
Biogen is seeking an experienced documentation coordinator to support the parenteral filling manufacturing area. The individual will perform coordination activities directly associated with production documentation, including but not limited to batch production records (BPRs). Responsibilities include reviewing executed batch production records, generating and reviewing production reports, and managing the overall batch record review process. Coordinating directly with manufacturing associates, leads, and supervisor, the coordinator will ensure the batch record review process is performed in a timely and efficient manner. The coordinator will act as a single point of contact for various groups (QA, engineering, maintenance, etc.) to support release of production batches, prioritize batches for record review, and coordinating completion activities.
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What You’ll Do
Oversee and manage the BPR review process, including review of execute BPRs, batch reports, and material reconciliation. Act as a single point of contact for QA, QC, engineering, maintenance, and manufacturing sciences, to ensure BPRs are accurately reviewed to support the overall batch release process.
Coordinate directly with manufacturing associates, leads, and supervisors, to ensure the BPR review is performed in a timely and efficient manner
Ensure proper prioritization of BPR review based on standard cycle times, as well as expediated cycles times as required
Maintain batch data collection and management, ensuring that batch data is appropriately maintained and reviewed
Support in the creation and maintaining of area and site metrics related to BPR reviews, batch processing time, and batch release. Identify areas of improvement and support various continuous improvement activities, working as part of a cross functional team.
Work to establish and maintain a safety focused culture. Proactively identify and remediate near-miss safety hazards.
Who You Are
You are organized individual with a strong attention detail and background in GMP manufacturing. You enjoy problem solving, continuous improvement and contributing a collaborative team environment.
Qualifications
Required Skills
Certificate / High School diploma with 5+ years of GMP industry experience. Experience in shop floor manufacturing and GMP documentation management preferred
Familiarity with cGMP documentation requirements
Exception communication skills, to effectively communicate through all levels of the organization
Experience working in cross functional teams, preferably in manufacturing environment
Ability to act independently, guided by area objectives
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.