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. 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.
This position includes maintenance and oversight activities of the Quality System associated with Document Control. Specifically, the role will maintain Document Control procedures as well as participation in the development and deployment of Document Control tools and Document Management System. The role will include activities related to the issuance, filing, reconciliation and archival of controlled documents. This position requires a background in QA, technical writing skills and inter-departmental collaboration.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Author and maintain Document Control procedures and templates.
- Provide support for the development and maintenance of site documentation, procedures, work instructions, and templates.
- Participate in the development and roll-out of document control tools.
- Issue production batch records and labels for manufacturing operations.
- Issue logbooks, protocols, reports and other controlled documents for various departments.
- Follow policies, SOPs and work instructions to support the document approval process.
- Develop and deliver training regarding document control processes and system changes.
- Execute the process for filing, reconciliation and archival of controlled documents.
- Support internal and external audits and regulatory inspections as required.
- Perform routine and ad hoc document control metric reporting and analysis.
- Monitor documentation system function; investigate and coordinate with IT on issues.
- Communicate the status of deliverables to customers, management, and stakeholders.
- Work on complex documentation problems, analyzes procedures and data to create appropriate solutions.
- Support Change Control related to Document Control processes, when required.
- This position is a delegate for other Document Control Specialists and, depending on level, this position may be a delegate of the Document Control Supervisor.
KNOWLEDGE, SKILLS, AND ABILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Strong understanding of cGMPs and quality systems.
- Excellent problem solving skills.
- Excellent project management skills.
- Excellent technical writing skills and verbal presentation skills.
- Excellent organizations skills and attention to detail.
- Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel).
- Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Ability to exercise judgment within defined practices and policies in performing Document Control functions with input from Supervisor.
- Ability to work independently on routine work tasks, and under only general instructions on new assignments.
- Ability to interact constructively and efficiently with co-workers within and across departments.
EDUCATION and/or EXPERIENCE
- BS/BA in science-related field desired; combination of education and related work experience may be considered.
- Previous experience in QA or related document control experience, as required below:
- Specialist I – 0 – 2+ years
- Specialist II – Minimum 2 years
- Specialist III – Minimum 5 years
- Experience with relevant software and databases required (e.g. MasterControl Document Management System, TrackWise, or similar system)
- Experience interacting with FDA or other regulatory agencies strongly preferred.
$23.31 - $49.55 per hour
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.