Manufacturing Documentation Specialist

About AGC Biologics  
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  

JOB SUMMARY

The Manufacturing Documentation Specialist supports AGC Biologics operations by reviewing all inputs necessary to complete the Manufacturing review of completed Master Production Records (MPRs). Inputs may include batch records, logbooks, equipment software and Trackwise. The Manufacturing Documentation Specialist works cross-functionally with multiple departments to provide data and coaching to promote continuous improvement in document execution.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Performs independent review of GMP documentation and partners with others for corrections as necessary, paying close attention to detail and maintaining an organized work process.
• Coordinates with Manufacturing and Quality to complete corrections for API release.
• Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
• Accesses systems including Unicorn, BMRAM, AX, and others to retrieve data for batch record completion.
• Obtains information from logbooks and assists with GMP logbook review.
• Participates in MFG operations meetings and gives updates pertaining to batch record review and deviations.
• Supports additional projects including data gathering, utilizing trackers, scanning records as needed.
• May participate in side projects related to continuous improvement efforts.

LEADERSHIP SKILLS

• Ability to communicate decisions and recommendations with clear justification.
• Ability to work under only general direction and independently determine and develop approach to solutions.
• Ability to resolve conflicts and address workplace issues in professional and collaborative manner.

QUALIFICATIONS 

Required:

• BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
• 0-2 Years Experience in GMP Environment

• Ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Demonstrated strong understanding of procedures and methods for document review.
• Ability to develop strong understanding GxPs (GMP preferred) and concepts in several quality systems.
• Ability to communicate data collected from batch record review.
• Understanding or willingness to learn AGC Biologics manufacturing processes.
• Ability to maintain a positive attitude and multi-task in a fast-paced environment, with changing priorities.

Preferred:

• Experience working in a regulated environment preferred.
• Experience working with GMP manufacturing batch records preferred.
• Experience working with Lean or Six Sigma concepts preferred.

COMPENSATION RANGE:

$36.00 - $45.00

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.