Sr Manufacturing Documentation Specialist
- Location: Morrisville, NC
- Type: Direct Hire
- Job #37746
The Sr Manufacturing Documentation Specialist is accountable for driving results in a fast-paced manufacturing environment by effectively performing the activities as directed to ensure batch execution and documentation are completed in compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and inspections and maintaining manufacturing documents and logbooks. The position assists with the development of SOPs or other manufacturing documents as needed. The incumbent will also own assigned manufacturing job codes and perform training for the manufacturing team. The position requires proven ability to get results in collaboration with other departments (Validation, Quality, Engineering, Supply Chain, Tech Services and others). The position requires superior leadership behaviors of the companies core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Performs post execution review and correction (as needed) of manufacturing generated documents or reports (batch records, logbooks, SOP revisions, Product and Process Validation Reports and others).
- Collaborates with other stakeholders in development/revision of batch records, SOP’s and other change control documents.
- Provide training on new or updated documents. Monitors training effectiveness during floor execution.
- Perform real time investigation and timely closure (<30days) of manufacturing deviations.
- Assist OPS Management and QA: Open, Follow up, deviations and CAPAs.
- Maintains regulatory commitment tracker and lead closure to agreed or pertinent timelines (Deviations, Batch Records, CAPA’s, CC’s, MCC’s)
- Review and disposition validation documents. Ensure effective training and line readiness prior to execution.
- Maintain the manufacturing inventory for general supplies.
- Assist QA on Investigations.
- Keep SOPs updated (Process and Procedures). Serve as the Manufacturing TRNP SOP’s trainer.
- Assist the Manufacturing leadership in achieving scheduling requirements.
- Work directly with QA personnel to ensure closure of deviation and batch production record.
- Assist manufacturing leadership in break coverage as needed.
- Complies with company policies and SOPs.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
- Bachelor’s degree in relevant field with a minimum of 5 years of related experience required.
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.
Core Leadership Competencies
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
- Knowledge of regulations and SOPs applicable to area of responsibility.
- Good written and oral communication skills.
- Good problem solving and analytical skills.
- Good computer skills and knowledge of Microsoft Office products.
- Perform investigation using root cause analysis. Knowledge of Master Control or any electronic change control system.
- Ability to interact well with employees at all levels.
Decision Making and Supervision Required
- Applies job skills, company policies and SOPs to complete a variety of tasks.
- Receives general instructions on routine work, detailed instructions on new projects or assignments.
- Up to 5% travel required.
Physical Demands and Work Environment
The physical demands work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Stand for long periods of time, work gowned up for long periods of time, maintain good personal hygiene.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. Ability to work in a high demand office and manufacturing setting with extended time with “on the floor” activities (in the manufacturing core). Position may require extended hours including evenings and weekends.
The employee is required to wear the appropriate personal protective equipment to perform the job duties. Business needs and deadlines will require employee to perform work duties outside of standard work hours on occasion.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
What We Offer You:
• Competitive salary with career advancement opportunities
• Bonus plan
• Medical, dental and vision coverage from day one
• 401(k) with company match
• Company paid vacation, holiday and sick-leave
• Voluntary benefits including short & long-term disability, life, accident, critical illness insurances