AMRI Quality Assurance Specialist - 2nd Shift in Burlington, Massachusetts

The Quality Specialist will provide support to the Quality Assurance organization – cGMP Compliance function at AMRI Burlington. S/he must be highly organized; self-motivated and have the ability to prioritize the workload. S/he will work closely with other departments/groups to maintain a high level of cGMP compliance in all regulated activities. S/he will support the development and maintenance of Quality Systems including; deviations/investigations, change control, auditing programs, CAPA, review and approval of validation protocols, and training.

Position Responsibilities

/Other duties may be assigned/

  • Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications

  • Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.)and batch records

  • Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation

  • Authors or revises SOPs

  • Performs manufacturing area and labeling clearances as well as inspection of material

  • Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports

  • Assists in performing investigations

  • Performs internal audits and weekly walkthroughs

  • External audits for Supplier qualification

  • With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues

  • Assists in developing and delivering training

  • Performs tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs

  • Develops and/or maintains Quality System metrics for Management Review

  • Provides on the floor support to manufacturing operations

  • Perform QA visual inspection activities associated with clinical and commercial drug product.

  • Participate in regulatory and client audits.

Education:Bachelor’s degree in life science field

Relevant Work Experience: 4-6 years’ experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 2 years’ experience in Quality Assurance

Knowledge, Skills & Abilities:

· Excellent written and verbal presentation and communication skills

· Strong facilitation skills

· Strong problem solving skills, with the ability to resolve conflict

· Ability to effectively present information to management and/or peers

· Comfortable working independently in combination with individuals in other departments across the organization

Job: *Quality

Organization: *AMRI Burlington

Title: Quality Assurance Specialist - 2nd Shift

Location: MA-Burlington

Requisition ID: 1000946

EOE Protected Veterans/Disability