Construction Inspection Services Manager jobs in New Hampshire

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

This position is responsible for performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives.

This individual’s primary job function will be to ensure finished drug product vials manufactured by PCI are free of visible defects which are culled through the visual inspection process to support patient safety and product quality.

• Records production quantities and other applicable information with adherence to Good Documentation Practices
• Applies a moderate level of math skills to include piece counting, time calculations, and product reconciliation
• Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations
• Acquires and maintains qualifications to inspect one to two types of product (i.e. clear lyophilized product, clear liquid product, Opaque product, etc.)
• Performs daily cleaning of visual inspection and packaging areas in accordance with established procedures
• Identifies and communicates product quality issues
• Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines
• Supports finished product packaging operations
• Effectively communicates both verbally and in writing with all levels
• Maintains a high level of integrity while balancing all job responsibilities
• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice
• Basic computer skills are required.
• Able to understand and follow instructions
• High school diploma or equivalent required
• Previous experience with GMP’s, SOP’s and working in an FDA / EU regulated environment is desired
• High school diploma or equivalent required
• Attention to detail
• Basic verbal and written skills
• Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
• Must be able to maintain visual qualifications : (20 / 20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products
• Must be able to work while wearing PPE for all GMP areas for an entire shift (Includes non-latex gloves, hair beard covers and lab coats)

Lifting / Pushing / Pulling note # Lbs. Up to 20 lbs.

Walking

Standing

Bending

Kneeling

Sitting 75% of the time

Additional :

• Able to follow written instructions
• Able to communicate with peers in a professional manner
• Able to work as a team
• Interacts with all Visual Inspection staff on a daily basis
• Communicates and Collaborates with Quality, Materials Management departments and other departments as needed.

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Last updated : 2024-05-24