Manufacturing Documentation Specialist
6 days ago
Job Title: Manufacturing Documentation Specialist
Job Summary: We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. The successful candidate will be responsible for supporting the development and maintenance of high-quality documentation for our manufacturing operations.
Key Responsibilities:
- Support the creation and revision of SOPs, Batch Records, Deviations, CAPAs, and other documentation related to manufacturing operations.
- Lead teams investigating minor, major, and critical non-conformances and deviations, including gathering information through structured root cause analysis.
- Own and manage change controls associated with manufacturing areas and equipment.
- Participate in technology transfer, conference calls, and sharing of technical information.
- Coordinate front-end document requests with supporting departments.
- Ensure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
- Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
Requirements:
- Minimum bachelor's degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Minimum of 2 years of experience in biopharmaceutical-based GMP manufacturing operations.
- Demonstrated strong technical knowledge of aseptic processing in cleanroom environments.
- Ability to build relationships quickly and credibly, with excellent communication and organizational skills.
- Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Ability to deal with ambiguity and manage constant change.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Excellent presentation skills, both written and verbal.
- Understanding of quality standards and requirements as documented.
- Strong computer skills, problem-solving, and attention to detail.
- Familiarity with data and sample management required (LIMS/MES).
Work Environment:
- This position will work in both an office and a manufacturing cleanroom setting.
- When in the lab, must be able to work in a cleanroom setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in a cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
Physical Demands:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Able to stand and/or walk 90% (and sit 10%) which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
Mental Demands:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
- Ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Travel:
- May require up to 10% travel, based on business need.
Salary and Benefits:
- Salary target ~$75-85K base, 10% bonus target, will have bonus and long term incentives (stock).
How to Apply:
Please submit your application, including your resume and cover letter, to [insert contact information].
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