Job DescriptionJob Title
Senior Quality Assurance Specialist
Requisition
JR000014050 Senior Quality Assurance Specialist (Open)
Location
Field Based Location - USA082
Additional Locations
Bridgewater, NJ, Chicago, IL, Detroit, MI, Jacksonville, FL, Little Rock, AR, Louisville, KY, Nashville, TN, Omaha, NE, Philadelphia, PA, Raleigh, NC, Richmond, VA
Job Description
The Senior Quality Assurance Specialist supports externally manufactured products for Mallinckrodt with a product portfolio that includes pharmaceutical and biopharmaceutical products. The Senior Quality Assurance Specialist is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional MNK team members. The Senior Quality Assurance Specialist 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
Management and 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.
Quality/QMS Projects
As required.
Champion continuous improvement efforts for projects identified at the CMOs or within Mallinckrodt
Minimum Requirements
Bachelor's Degree in scientific discipline,
7+ years' experience working as QA Specialist required, 10+ years preferred
Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485
Strong sterile manufacturing and/or microbiology background
Excellent interpersonal skills: ability to communicate well, both verbally and written
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
Lead continuous improvement projects
CQA and/or CSQP certification preferred.
Organizational Relationship / Scope:
The position reports to the Quality Operations Senior Manager.
Working Conditions:
This position works in an office type environment. Long periods of sitting are required. Use of computer and phone are required on a daily basis. This will require EST or CST working hours. Travel is expected routinely 1-2x per month.
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Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.