Boehringer Ingelheim Senior Associate, Batch Record Reviewer / Technical Writer in FREMONT, California
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Creates manufacturing Batch record templates for multi-product. Writes, and edits technical documents related to bio-manufacturing by working seamlessly with cross functional teams under general supervision. Has advanced Microsoft Word skills and balances accuracy with speed under pressure, creating efficient documents while remaining compliant with the regulatory requirements. Sets priorities to ensure documents are ready when needed per the production schedule.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities:
Creates or revises and manages the workflow for MFG documents:
Checks out the document
Determines reviewers/ approvers based upon the changes requested and the document type
Obtains technical content from Subject Matter Experts (SMEs) and drafts new / revises existing documents using current templates
Follows up with the reviewers/ approvers and address comments
Coordinates the document workflow in BIFI documentation management system (IDEA for CON)
Drives consistency within the document, between documents, such as:
Formatting (date/time consistency, documentation consistency, etc.)
Chunk information so that it is easily digestible
Spacing consistency in the document (ensure there is enough space to attach attachments and to write content)
Step number references
Batch record flow should be consistent across different products and learnings from a particular campaign should be carried forward to the next set of batch records.
Facilitates meetings to resolve / address comments (if the document revision is extensive), and to reach consensus with multiple stakeholders.
Performs other related duties and responsibilities, on occasion, as assigned.
High school degree required and minimum two (2) year work experience in GMP regulated industry; Associates/Bachelor’s degree or biotechnology vocational training from an accredited institution preferred.
Knowledge of Biologics with bio-manufacturing and documentation management system processes experience.
Advanced proficiency in MS Word and intermediate proficiency in MS Visio.
Technical writing experience of one (1) year with a certificate in Technical writing is highly desirable.
Quick learner, understanding of presented technical/scientific content.
Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
Keen attention to detail and high regard for quality.
Experience working in a self-driven, performance/results oriented, fast paced environment.
Willingness to take on new challenges.
Able to adapt to changing needs caused by time, budget, or other constraints.
Must be highly collaborative; have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community.
Bio-manufacturing floor operations, training, validation, quality assurance experience in a bio-pharmaceutical industry
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Fremont
Title: Senior Associate, Batch Record Reviewer / Technical Writer
Requisition ID: 1814549