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Coordinates biopharmaceutical manufacturing batch records, controlled documents, training packets, and production binders. Reviews records for completeness, accuracy, GMP compliance, ALCOA principles, and data integrity. Supports quality events, CAPAs, investigations, manufacturing planning, document revisions, controlled-form reconciliation, and documentation quality metrics. Communicates with manufacturing and cross-functional teams to resolve issues, manage timelines, and complete administrative tasks.
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Become a vital member of our team as a Batch Record Coordinator, ensuring top-quality events and actions. You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also managing administrative tasks and revising documents. Ready to make a big impact? This role is for you!
- Assist in quality events and corrective and preventive actions.
- Assist in compiling and review of data for investigations, reports, and batch history records.
- Reviews executed batch records for completeness, accuracy, and adherence to ALCOA principles, ensuring all GMP documentation meets internal and regulatory standards.
- Support Manufacturing activity planning.
- Communicate with Manufacturing staffs, supervisors, and members of other departments, as appropriate, to ensure prompt resolution of problems.
- Oversee timelines for document revision and sign off.
- Collect, submit, and file controlled documents.
- Prepare, issue, maintain and reconcile controlled forms used in Manufacturing.
- Coordinate and prepare Manufacturing training packets and associated forms (batch production records, BSS, planned QEs) when applicable.
- Prepare binders with associated batch records, forms and labels required for production processes or formulations.
- Creates and maintains RightFirstTime (RFT) and documentation quality metrics, including trends on corrections, GDP deficiencies, and data integrity performance.
- Review records for completeness.
- Follow company policies and procedures.
- Assist Sr. Document Coordinator.
- Perform duties per cGMP guidelines.
- Prepare and compile GMP Batch History Record Binders.
- Issue and reconcile controlled forms used in Manufacturing.
- Make editorial changes to controlled documents and reports.
- Distribute controlled documents (Doc Control).
- General administrative responsibilities – making copies, filing, scheduling and ordering office supplies.
- Revise Batch Production Records, SOPs, and other controlled documents.
- Other tasks may be assigned as needed.
Minimum Qualifications:
- High school diploma or GED; or equivalent combination of education and experience relating to administrative or clerical duties.
- Attention to detail.
- Sense of urgency.
- Excellent organization and communication skills (written and verbal).
- Adherence to timelines.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday. Must be available to work holidays, weekends, or extended hours when needed.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $16.68 to $22.26 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Avid Bioservices Tustin, California, USA Office
14191 Myford Rd, Tustin, California, United States, 92780 7020
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