Quality Control Manager Job Flowery Branch area,Georgia USA,Quality Assurance

Job Description

Main Accountabilities and tasks

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office
The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for QC and transfer activities
These activities include the timely qualification of in-process and release testing of drug delivery systems, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory
The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly
Review and approval of customer manufacturing batch record
Responsibilities include hiring, training, goal setting, and performance evaluation
The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions
Additionally, the manager serves as the primary technical liaison with clients and Regulatory Bodies
Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing
Build a trained, competent team of QC analysts to support GMP testing
Coordinate any required daily Quality Control activities
Ensure compliance, accuracy, and timeliness of testing processes
Lead the introduction of new technology, equipment, methodologies, and validations
Provide QC leadership and support across the organization
Hire and develop employees within the department
Assign work, coach staff, and take vital disciplinary actions
Serve as primary QC Bioanalytical contact for regulatory inspections and client audits
Provide support for method qualification and validation from Assay Development and Analytics and/or clients
Provide frequent overall departmental feedback to senior management
Ensure adequate staffing is hired and trained

Qualifications

Work Experience

5-7 years of experience manufacturing in a highly regulated quality control lab environment.

Education

Bachelor’s degree

Other

Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required

Experience with regulatory inspections from the FDA, EMA, Notified Body, or other regulatory authorities required

Capable of writing reports, business correspondence, and procedure manuals

Strong organizational skills with the ability to prioritize and lead through complex processes/projects

Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents

Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community

Ability to effectively present information to employees, top management, public groups, and/or boards of directors

Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form

Ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems

Able to lead abstract and concrete variables in situations where only limited standardization exists

Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.

Ability to work well with subordinates, peers, and superiors in all departments.

Additional Information Benefits we offer

An innovative, vibrant and agile culture
Growth opportunities in a globally successful and dynamic business on a growth trajectory
Excellent employee benefits including:
- Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
- Employee Savings Plan / 401k with 100% employer match

Compensation

$110,000-$110,000 per year

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