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Biolyph Llc

Senior Quality Manager

Chaska, MN, United States

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Job details

Posting language: English

Original job description

BIOLYPH is growing! We are seeking an experienced, team-oriented, and responsive Senior Quality Specialist. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, growth opportunities, and a culture of life-work balance. The Senior Quality Manager is BIOLYPH's appointed management representative of the Quality System. This role is primarily responsible for developing the strategic vision for the entire Quality department, representing the vision to Executive Management, hiring and leading the department employees, and establishing and monitoring policies and procedures at all levels. In addition, they are fully responsible for the health of BIOLYPH's QMS and work cross-functionally to meet or exceed BIOLYPH's and our Clients' needs and expectations.

Essential Functions:

Quality System Representative:
Maintain a Quality Management System (QMS) that models the intent of ISO 13485 and cGMP (21 CFR Part 820) through documentation, training, and implementation
Identify opportunities to proactively assure compliance to applicable internal, domestic, and international quality regulations
Formulate, maintain, and communicate quality objectives complementary to BIOLYPH's policies and goals
Report QMS status, lead Management Review meetings, and monitor QMS-related deliverables
Review and disposition QMS modifications
Participate in Continuous Improvement activities
Demonstrates effective Change Leadership
Management:
Coordinate across functional areas, business units, and/or geographies to achieve company or area goals
Identify and manage activities related to adding value to the organization through risk reduction and cost improvement
Evaluate and escalate the need for additional team resources
Accomplish department objectives by managing staff, planning, and evaluating department activities
Complete and deliver Employee Performance Assessments
Quality Systems:
Facilitate document control and document retention activities
Review and disposition change controls, deviations, corrective actions, Client complaints, procedure updates, and other Quality System documentation
Direct the development and implementation of job-specific training tools across the organization
Manage and direct Supplier Management program, including conducting quality audits and generating audit reports
Production Support:
Champion BIOLYPH's goal of Perfect Finished Parts
Assist with daily production quality questions/issues
Serve as the point of escalation/contact as business needs dictate
Client Support:
Establish and maintain relationships with Client Quality Representatives

Secondary Job Functions:

Support the Production Team as needed
Perform miscellaneous duties and projects as required

Qualifications:

Bachelor's Degree in Life Sciences or Chemistry
Five plus years of experience in a demonstrated Quality Leader role
Quality Assurance experience in an FDA-regulated manufacturing or other technical environments
GMP/GDP experience
Experience building and maintaining Quality Management Systems (preferred)
ISO 13485 experience (preferred)
Quality certification, CQIA, CMQ, or CQE (preferred)

Other Requirements:

Organized with close attention to details
Advanced written and oral communication
Time management and prioritization skills
Excellent computer skills (Outlook, Word, Excel)
Capable of applying Quality Tools to diverse situations
Proven leadership
Performance management
Project Management
Data analysis skills
Presentation skills
Capable of working independently and as a team
Must be able to wear appropriate PPE
Ability to sit for extended periods of time
Normal vision acuity (with or without corrective lenses)
Ability to identify and distinguish colors
Ability to lift 10 lbs routinely/often/occasionally
Ability to crouch, bend, twist and reach
Ability to push/pull 25 lbs occasionally

About BIOLYPH:

Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. BIOLYPH has maintained a workforce that is collaborative and innovative.

BIOLYPH Offers:

Competitive pay commensurate with experience
Benefits for full-time employees include:
Health, Dental, Vision, Life, Short-term, and Long-term disability insurance
Paid Time Off, Paid Holidays including Floating Holidays, Paid Birthdays
401k
Employee Assistance Program
Frequent company-sponsored events
Clean, friendly, and collaborative work environment

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More about this job

Skills

Quality assurance procedures
Documentation
Regulatory compliance
Process improvement
Leadership
Quality control systems
Vendor management
Quality assurance
Good manufacturing practices
Communication skills
Time management
Prioritization
Computer skills
Microsoft Outlook
Microsoft Word
Microsoft Excel
Performance management
Project management
Data analysis
Presentation skills
Work independently
Tolerate sitting for long periods

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