The Quality Assurance Specialist supports externally manufactured products for *** 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
o Preparation, review and approval of CMO documentation for batch production
o Review of batch records, addressing discrepancies and escalating where required to management.
o Preparation of disposition and release certification for reviewed batch records.
" CMO Governance
o Support the oversight of third-party supplier activities relating to the manufacture, packaging and testing of product.
o Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
o Continuous monitoring of product and performance from CMOs.
" Quality Support and Deputation
o Quality record management; deviations, change controls, CAPAs
o Monitoring cold-chain transportation, for both qualification and routine
o CMO Maintenance
o Input into Technical Quality Agreements
o Post-launch support for quality activities in various countries
o Management of delegated projects
" Stability Program
o Protocol review and approval
o Data review and management
" Audits
o Drive the audit readiness program to ensure audit compliance at all times.
o Perform supplier audits as required (CQA certification preferred)
" Quality/QMS Projects
o As required.
" Champion continuous improvement efforts for projects identified at the CMOs or within ***
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
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
Organizational Relationship/Scope:
The position reports to the Quality Operations Senior Manager.
Working Conditions:
This position works in an office type environment, although primarily remotely. Long periods of sitting are required. Use of computer and phone are required on a daily basis.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.