Senior Quality Assurance Specialist

Found in: beBee jobs US - 3 weeks ago


Detroit, Michigan, United States Mallinckrodt Pharmaceuticals Full time

Job TitleSenior Quality Assurance Specialist

Requisition
JR 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.

#LI-LM1

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 stat



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