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18 days old

Quality Director- Product Testing & Lab Systems

Kelly Services
Alachua, FL 32616
+ Job Title: **Quality Director- Product Testing & Lab Systems**

+ Location: **Alachua, FL**

+ Salary: **$180-190k**


**Job Responsibilities** (core responsibilities; include people management if applicable)


Accountable for the development and lifecycle management of the QC laboratory operations, including but not limited to sample management, in-process, release and stability testing, laboratory equipment maintenance, data trending, laboratory investigations, execution of method validation and stability study protocols.


+ Raw Materials and Product testing (in-process, release, stability)

+ Acts as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for in-process, release and stability testing. Ensures compliance of selected QC laboratory equipment to Part 11 and Data integrity regulations and guidelines.

+ Sample management and testing schedule management.

+ Primary point of contact for QC operations for Client projects. Acts as liaison with Clients for site specific QC operations. Oversight of contract testing labs (raw material and product)

+ Execution of Analytical method comparability studies

+ Retain sample storage and inspection.

+ Management of site lab E-Systems workflows (EM, LIMS, LES, etc)

+ Responsible for developing and reporting of QC related metrics e.g., sample TAT and release, invalid and OOS data,

+ Execution of method transfer, validation, and compendial method verification

+ Data review

+ Schedules, reviews data and oversees testing of materials, intermediates and drug products. Ensures timely completion of testing deliverables in accordance with commitments made to Clients and corresponding Quality Agreements.

+ CoA generation/issuance.

+ Laboratory investigations management.

+ Providing expertise and support for product investigations, improvements to ensure continue compliance with regulations. Overseeing complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis, and risks assessments.

+ Product Specifications & associated sampling plan.

+ Method Performance monitoring.

+ Critical reagents/reference standards & material management and qualification

+ Technical support for Commissioning & Qualification and CSV including potential execution of test scripts (lab instrumentation and equipment)

+ Lab coordination with Facilities & Engineering for preventive maintenance and calibrations (lab instrumentation and equipment)

+ Accountable for recruiting talent and building a high-performance QC team. Mentors and develops personnel and ensures teams agility, versatility and expertise redundancy.?

+ Establishes requirements and develops on-the-job-training plans for the QC team. Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures.

+ Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goal

+ Develops user requirements and contributes to the validation and implementation of the Laboratory Information Management System (LIMS) and electronic laboratory notebook

+ Responsible for the development and lifecycle management of site-specific QC standard operating procedures and associated records

+ Provides input and manages execution of method validation and verification for testing conducted at the site

+ Maintaining a safe, efficient, functional and compliant laboratory

+ Sustaining a continuous state of inspection readiness.

+ Directing the development, planning, implementation and maintenance of test methods, processes, and operations

+ Developing and implementing strategies to continuously improve data management practices and assuring data integrity

+ Actively influencing the development and formalization of corporate laboratory control standards and procedures

+ Manage budget?for?department and project?resources.

+ Member of site operational cross functional leadership team


**Preferred Experience, Education & Qualifications** (Education/Degrees/Certifications)


+ Bachelors degree of higher in Life Sciences, Biology, Engineering, or related field

+ Minimum of 15 years of pharmaceutical or biotechnology industry experience, with minimum of 7 years in a quality oversight function

+ Comprehensive knowledge of global GMP regulatory requirements for quality control laboratory operations, data integrity, and stability protocols.

+ Strong Bioassay expertise.

+ Hands-on experience with oversight of GMP laboratory operations at a biologics facility

+ Previous managerial experience, with proficiency in hiring talent and managing performance


**Other Ideal Preferred Characteristics:**


+ Broad Quality and Regulatory CMC experience, including:

+ Knowledge of biotechnology development, processing and testing

+ Compendial test methods


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-10 Expires: 2022-07-11

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Quality Director- Product Testing & Lab Systems

Kelly Services
Alachua, FL 32616

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