Asepsis, Biology, Biotech and Pharmaceutical, Coaching, Communication Skills, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Depth Perception, Detail Oriented, Documentation, External Audit, Internal Audit, Manufacturing, Manufacturing Operations, Manufacturing Requirements, Medical Products, Metrics, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Physical Demands, Presentation/Verbal Skills, Process Improvement, Quality Assurance, Regulations, Root Cause Analysis, Source Code/Configuration Management (SCM), Staff Training, Supply Chain, Support Documentation, Team Player, Time Management, Training/Teaching, Willing to Travel, Writing Skills
Morrisville, North Carolina
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job Summary:
The Associate Manufacturing Specialist is accountable for driving results in a fast-paced environment by being responsible to manufacture various products following a specific protocol while in full compliance with all cGMP procedures and guidelines.
The Associate Manufacturing Specialist is responsible for handling, reviewing, and ensuring the accuracy, completeness, and compliance of all manufacturing documentation associated with formulation and aseptic filling operations. This role ensures that Good Documentation Practices (GDP) are consistently upheld and that batch records are processed efficiently to support on-time product release.
On-Site Expectations:
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 4:30pm.
Responsibilities:
Batch Record Handling & Review:
- Receive, organize, and manage all formulation and aseptic filling batch records and associated documentation.
- Perm detailed review of batch records for accuracy, completeness, and compliance with cGMP, GDP, and internal SOPs.
- Identify, document, and facilitate resolution of discrepancies, errors, and missing information / reports.
- Ensure timely completion of record review to meet established batch release timelines.
- Provide feedback and training to manufacturing technicians to support right first-time manufacturing initiatives.
- Perform logbook reviews and support corrective action as necessary.
Documentation Quality & Compliance
- Serve as subject matter resource for GDP requirements across manufacturing teams.
- Ensure documentation is legible, traceable, contemporaneous, accurate, and compliant with regulatory expectations.
- Maintain control of revision processes and ensure the correct versions of forms and records are in circulation.
- Support internal and external audit readiness by ensuring documentation accuracy and availability.
Training & Continuous Improvement
- Train manufacturing personnel on proper documentation practices, batch record / logbook review, and general batch record handling expectations.
- Provide feedback and coaching to operators and supervisors, to strengthen compliance culture.
- Participate in root cause analysis for documentation-related deviations or recurring errors.
- Recommend and support implementation of documentation process improvements.
Cross-Functional Support
- Work closely with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs and timelines.
- Support investigations by providing relevant documentation insights and historical reference.
- Assist in preparing documentation summaries or metrics for management review.
- May require periodic presence on the production floor.
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related field preferred; equivalent experience considered.
- Must have 1 - 3+ years in related GDP environment. Pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred.
Knowledge, Skills, and Abilities:
- Experience with batch record review, GDP, or cGMP environments highly desirable.
- Strong attention to detail and ability to identify errors and inconsistencies.
- Strong verbal and written communication and documentation skills required.
- Strong detail orientation and organizational skills required.
- 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) required.
Travel Expectations:
- Up to 5% travel required.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must 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, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.