Quality Assurance Specialist-Intermediate

Mindlance

🇺🇸 United States
On-site
Mid level
1 day ago

CMOS

1 day ago

Not enough detail in this posting to match

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.”

Quality Assurance Specialist-Intermediate · Mindlance

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