Associate Manufacturing Specialist
On-siteMorrisville, North Carolina, United States
Job Summary
Review and manage formulation and aseptic filling batch records, ensuring accuracy, completeness, and compliance with cGMP, GDP, and internal SOPs. Identify discrepancies, document errors, and facilitate resolutions to meet batch release timelines. Train manufacturing personnel on documentation practices and provide coaching to strengthen compliance culture. Serve as a subject matter resource for GDP requirements, maintain control of revision processes, and support audit readiness. Collaborate cross-functionally with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs and timelines. Participate in root cause analysis for deviations and recommend process improvements. Work Monday through Friday, 8:00am to 4:30pm, with up to 5% travel required.
Required Qualifications
- 100% on-site position
- 1st Shift: Monday - Friday, 8:00am - 4:30pm
- Must have 1 - 3+ years in related GDP environment
- Pharmaceutical, biotech, or aseptic manufacturing operations work experience
- Experience with batch record review, GDP, or cGMP environments
- Strong verbal and written communication and documentation skills
- Strong detail orientation and organizational skills
- Ability to collaborate cross-functionally and provide constructive feedback
- Ability to manage multiple priorities in a fast-paced environment
- Ability to work extended hours during peak production or release periods
- Able to work with Microsoft Office (Word, Excel, PowerPoint)
- Up to 5% travel required
- Must regularly lift and/or move up to 10 pounds
- Must frequently lift and/or move up to 25 pounds
- Must occasionally lift and/or move up to 50 pounds
- Must regularly use hands to finger, handle, or feel
- Must reach with hands and arms
- Must talk or hear and smell
- Must frequently stand
- Must occasionally walk
- Must occasionally sit and stoop, kneel, crouch, or crawl
- Must have close vision
- Must have distance vision
- Must have color vision
- Must have peripheral vision
- Must have depth perception
- Must have ability to adjust focus
- Must be frequently exposed to moving mechanical parts
- Must be frequently exposed to the risk of electrical shock
- Must be frequently exposed to burn hazards
- Must be frequently exposed to microbial contamination
- Must be occasionally exposed to fumes or airborne particles
- Must be occasionally exposed to toxic or caustic chemicals
- Must be occasionally exposed to vibration
- Must be required to wear appropriate personal protective equipment
Desired Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field preferred
- equivalent experience considered
- Pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred
- Experience with batch record review, GDP, or cGMP environments highly desirable
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