This function is responsible for Quality Assurance support of the facility and manufacturing operations. This function is the first line of contact and escalates events to Senior Associates when they are outside of the area of responsibility.
The position will perform general QA activities using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks.
Key Responsibilities:
On the floor manufacturing support including: on the floor batch record review, visual inspections of equipment and equipment release, discrepancy identification, logbook/document review, status tagging, work order review, and room/utility checklists
Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
Interact with plant personnel to insure cGMP compliance
Provides back up for other QA as appropriate
Monitoring of cGMP compliance throughout the facility and product lifecycle
Must be able to pass all assessment/certifications upon completion of training
Must be able to pass health assessment as part of job offer
Skills/ Abilities:
Must be able to pass Health Assessment as prior to start date
Must be able to wear aseptic gowning and PAPR suit/equipment for up to 4 hours at a time
Working knowledge of US Drug Product GMP requirements and associated guidelines
Strong written and oral communication skills
Experience in administration of quality systems for drug product manufacturing and quality control operations
Good computer skills
Personal Attributes:
Good work ethic, dependable, punctual, and flexible
Good motivator of personnel
Good team player with a can-do attitude
Can work in a fast-paced environment with multiple issues open simultaneously
Highly organized
Attention to detail
Identifies opportunities to improve and contributes to problem solving
EDUCATION:
Requires a Bachelor's degree in a scientific discipline or equivalent.
Pharmaceutical industry experience may be substituted for Bachelor's
EXPERIENCE:
Minimum of 1 year experience in a Quality Assurance role in the pharmaceutical industry preferred.
