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SalaryBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Document Control Coordinator role is a non-exempt position responsible for supporting the document management process within the Drug substance and Drug Product manufacturing facility to support both the validation documents and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage & retention, and document issuance &
reconciliation. The coordinator will ensure that the organizational documents are prepared, maintained, distributed, updated, and stored according to the organization’s document management standards.
Required Skills/Attributes:
- Support Document Management Operations team
- Oversee revision control
- Scan and file documents
- Supporting project tasks
- Supporting the Material Specification project team
- Processing controlled documentation within the customers system
- Formatting to structure batch record, forms, associated logbooks and data entry work • Logbook review
- Advising and responding to queries on document status by interfacing with operation management
- Demonstrated ability to successfully gown into aseptic manufacturing areas
- Excellent organization and time-management skills required
- Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure
- Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self Confidence & Ability to Accept & apply Lessons Learned as needed
- Works with a sense of urgency, while engaging and listening to experts
- Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills
- Strong organizational skills with the proven ability to prioritize
- Must be dependable and punctual
- Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
- Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs
- Customer/Client Focus
Responsibilities:
- Issuance of batch related documentation and labels in support of GMP manufacturing.
- Reconcile GMP documentation following document lifecycle requirements.
- Creation and issuance of GMP logbooks/notebooks.
- Responsible for storage and archival of GMP documents and batch related records.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Drive continuous improvement.
- Update functional teams with document status
- Support Document Management Operations team
- Oversee revision of Batch record, protocol and other control documents
- Scan and file documents
- Supporting project tasks
- Processing controlled documentation within applicable system
- Formatting to structure and formatting control record and data entry work
- Advising and responding to queries on document status by interfacing with operation management
- Responsible for the administration and management of Facilities Engineering records in an effective and efficient method within HPW facility
- Prepare and organize documentation procedures following
- Assist departments with equipment and system documentation. Coordinate system implementation and prepare documentation as necessary.
- Identify specific process improvement as needed and provide recommendations concerning established workflows.
- Work directly with Facilities Engineering and various Quality organizations.
- Maintain open communication with management, co-workers, customers and counterpart staff in other sites.
- Manage all Turn-Over-Packages (TOP) and Commissioning Packages from HPW site projects.
- Maintain open communication with management, co-workers, customers, and counterpart stain in other sites as needed (GZ)
Qualifications:
- High school education or GED required with 3+ years of related experience
- Bachelor’s degree / Associate degree / Vocational school or Prior industry or related field experience preferred
Key Relationships:
- Must attend both the DS and DP morning huddles.
- Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Supply Chain and Planning.
- Manage all Turn-Over-Packages (TOP) and Commissioning Packages from HPW site projects.
- Maintain open communication with management, co-workers, customers, and counterpart stain in other sites as needed(GZ)
- Work with Supply Chain to coordinate the manufacturing schedule in order to support the batch records, labels and forms requirements prior to the start of production. Production Support
- The position is also supporting the following to critical areas as needed basis:1. Drug Substance Area- Buffer and Media preparation as well as condonement preparation utilizing Autoclave and Parts washer. 2. Drug Product: Component preparation utilizing Parts washer and Autoclave
- Batch Records, Forms, Labels etc are all stored in the designated are on the manufacturing floor at least 2 days prior to the production run.
- Material Staging for Drug substance and Drug Product
Physical Requirements:
- Must be able to stand for long periods, up to 8 to 12 hours/day.
- Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Must be comfortable in working in varying temperatures.
- Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.
- Regular reaching, bending, stooping, and twisting.
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
- Environment requires dedicated gowns, depending on area.
- Work with hazardous materials and chemicals.
- Willing to work any shift.
Computer Skills: Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
