AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com .
SUMMARY:
The Document Control Technician will develop, establish, and maintain the Engineering Documentation System in a manner that ensures all identified technical documentation is inventoried and available to reflect the current status of all current equipment and processes on site. Develop, establish and maintain Engineering Documentation policies, processes, procedures and controls ensuring that the system and documents conform to established standards and agency guidelines. Track documentation through the full life cycle process. Ensure engineering compliance documents (Deviations, CAPAs, SOPs, etc.) are current and maintained in a compliant state.
PRINCIPAL RESPONSIBILITIES:
EDUCATION/EXPERIENCE:
COMPENSATION RANGE:
$66,960 - $92,070 annually
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
SUMMARY:
The Document Control Technician will develop, establish, and maintain the Engineering Documentation System in a manner that ensures all identified technical documentation is inventoried and available to reflect the current status of all current equipment and processes on site. Develop, establish and maintain Engineering Documentation policies, processes, procedures and controls ensuring that the system and documents conform to established standards and agency guidelines. Track documentation through the full life cycle process. Ensure engineering compliance documents (Deviations, CAPAs, SOPs, etc.) are current and maintained in a compliant state.
PRINCIPAL RESPONSIBILITIES:
- This direct management responsibility includes all support activities and functions necessary to ensure successful completion of Engineering documentation activities.
- Provides oversight and guidance to sustain compliance with Regulatory, Corporate and Site GMP processes for Engineering documentation, which includes all change controls, validation, commissioning, deviation, SOPs, and capital project files.
- Accurately maintains the on and off site controlled filing storage systems for current and historical records. Develops and maintains appropriate policies and/or procedures to be applied to all Engineering documentation regardless of source, location, or media type.
- Controls lifecycle documents within scope of department such as SOPs, forms, technical reports, vendor manuals, and Validation Protocols and Reports.
- Ensures that any revisions or updates are executed and recorded in accordance with procedure.
- Responsible for the coordination, control, storage, copying and retrieval of all Engineering Documentation. Develops, classifies, and reviews record retention schedules for Engineering Documentation. Periodically re-views and updates retention schedules to reflect changes in legal and/or operational requirements.
- Provides education and awareness to site employees regarding Engineering Document System and the documents available in the system.
- Maintains database tracking system for Engineering Documentation. Coordinates and maintains curricula and other training elements of the Engineering Group.
- Audits Engineering SOP's, document types, and training records to ensure compliance.
- Participates in all inspections and internal / external audits by facilitating document access and as assigned.
- Coordinates and tracks all department MasterControl actions and functions as lead deviation writer for the Engineering department.
- Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.).
- Performs other duties as assigned.
EDUCATION/EXPERIENCE:
- High school diploma required (AS technical degree preferred).
- Minimum of 4-6 years of experience with GMP documentation.
- Experience with pharmaceutical industry standards and requirements (Minimum US GMP).
- Basic understanding of the validation process.
- Demonstrated experience in using RCA processes.
COMPENSATION RANGE:
$66,960 - $92,070 annually
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.