Quality Assurance Specialist

Quality Assurance Specialist

Pay rate: $55.00- $57.00/hr Hours: M-F business hours (7:00-9:00 start with 8 working hour shifts), no overtime required Location: Remote- Remote, preferable NJ/northeast area; east coast or central time zone only Duration: 6 months, with potential to convert

The Quality Assurance Specialist supports externally manufactured products for Mallinckrodt with a product portfolio that includes pharmaceutical and biopharmaceutical products. The position is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional MNK team members. The position is responsible for appropriate escalation to Manager/Director level management and above.

Essential Functions

• Batch Review
• Preparation, review and approval of CMO documentation for batch production
• Review of batch records, addressing discrepancies and escalating where required to management.
• Preparation of disposition and release certification for reviewed batch records.
• CMO Governance
• Support the oversight of third-party supplier activities relating to the manufacture, packaging and testing of product.
• Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
• Continuous monitoring of product and performance from CMOs.
• Quality Support and Deputation
• Quality record management; deviations, change controls, CAPAs
• Monitoring cold-chain transportation, for both qualification and routine
• CMO Maintenance
• Input into Technical Quality Agreements
• Post-launch support for quality activities in various countries
• Management of delegated projects
• Stability Program
• Protocol review and approval
• Data review and management
• Audits
• Drive the audit readiness program to ensure audit compliance at all times.
• Perform supplier audits as required (CQA certification preferred)
• Quality/QMS Projects
• As required.
• Champion continuous improvement efforts for projects identified at the CMOs or within Mallinckrodt

Competencies

• Good interpersonal skills; ability to communicate well, both verbally and written
• Able to function effectively in teamwork environment
• Demonstrate ability to work independently
• Thorough, diligent and good attention to detail
• Collaborator with strong levels of engagement with individuals and team
• High level of delivery and work completion
• Strong organizational skills
• Support continuous improvement projects

Education / Experience / Skills

• Bachelor's Degree in scientific discipline, preferred
• 5+ (ideally 7+) years' experience working within Quality roles with increasing responsibility.
• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
• Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211 and CFR 820; knowledge of GDP and ISO 17025 and 13485
• Sterile injectable pharmaceutical experience required

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.