PRINCIPLE RESPONSIBILITIES:
· Reviews and/or approves records for compliance with SDIX procedures, ISO 13485 Standards and FDA Part 820.
· Assures that commercial finished products are manufactured, labeled, tested and packaged in compliance with industry regulatory standards, customer specifications and SDIX policies.
· Prepares organization for ISO 13485, FDA Part 820 and customer audits. Conducts internal audits according to Master Audit Plan. Reports findings to management and ensures corrective actions are addressed.
· Maintains master equipment list and monitors compliance of equipment maintenance program and associated records to SOP, ISO 13485 and FDA 820. Reports findings to management.
· Performs QA review of deviations, change controls, and validation reports. Reviews lot record and final release of finished product. Ensures nonconforming product is identified and reported.
· Reviews and approves Quality documentation, customer specifications and validation plans to ensure compliance with applicable regulations and standards.
· Maintains the document management system.
· Promotes Quality mindset and positive communication.
QUALIFICATIONS & ABILITIES:
· BS in biology, chemistry or related life sciences field.
· Minimum of two years QA-QC experience, preferable in biotech/pharmaceutical field.
· Experience in document control and equipment control systems including working knowledge of IQ/OQ/PQ and process and cleaning validation methodologies.
Abilities
· Experience in reviewing records and conducting audits.
· Working knowledge of quality system operation in a GMP and/or ISO environment.
· Computer literacy to include Microsoft Office Suite, data management systems and document control systems.
· Ability to handle competing priorities and deadlines for customers.
PHYSICAL DEMANDS:
Physical demands as described are representative of those required to successfully perform the essential functions of the position. Reasonable accommodations may be made.
Ability to lift or move 35 pounds and work/travel throughout plant environment of varied temperatures and humidity; see, grasp and hold small objects, a full range of motion, and to wear personal protective devices.
Job Type: Part-time
Expected hours: 20 – 24 per week
Experience level:
Schedule:
Work setting:
Experience:
- QA/QC: 2 years (Required)
Shift availability:
Ability to Commute:
- Windham, ME 04062 (Required)
Ability to Relocate:
- Windham, ME 04062: Relocate before starting work (Required)
Work Location: In person