About the Role

• We are seeking a dedicated Documentation Specialist to join our Manufacturing Support Team.
• This role involves working closely with shop floor production personnel and interfacing with Technical Support and Quality Operations.
• The ideal candidate will thrive in a fast-paced environment and demonstrate a hands-on approach when necessary.
• Attention to detail, a strong command of good documentation practices (GDP), and the ability to design and enhance documentation to meet Quality requirements are essential for success in this position.

Pay Range: $25 -$29

Responsibilities -

• Provide documentation support for vaccine production activities.
• Review batch records, logbooks, and electronic logbooks for errors, collaborating with Production, Quality, and other personnel to correct and clarify as needed.
• Support process documentation changes and improvements, including updates to batch records and standard operating procedures (SOPs).
• Maintain and utilize metrics for the manufacturing shop floor execution documentation program effectively.
• Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate.
• Utilize standard systems including MS Word, Excel, PowerPoint, Outlook, and Teams.

Education Qualification-

• Bachelor’s degree in Science, Engineering, English, Business, or a relevant discipline OR a High School Diploma with two years of related GMP Biopharma experience.

Required Skills -

• Ability to work independently and as a team member with integrity, precision, accomplishment, motivational ambition, respect, and inclusion. Strong critical thinking and problem-solving abilities.
• Working knowledge of cGMPs and regulatory requirements as they apply to the vaccine/pharmaceutical industry.
• Familiarity with documentation administration, including writing, reviewing, and approving documentation in a GMP industry.
• Completion and medical clearance for BCG medical clearance requirements: questionnaire, blood test, chest x-ray.