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14 days old

Lead - Product Quality Assurance

Kelly Services
Richmond, VA 23224
Kelly Scientific is seeking a **Lead - Product Quality Assurance near Richmond, VA.**


**Direct Hire**

**Shift:** Monday - Friday 8am-5pm. Hybrid schedule. 3 days in office; 2 days remote

**Compensation:** based on experience


**_Relocation assistant provided!_**

**Responsibilities:**


The responsibilities of this job include, but are not limited to, the following:


+ Ensure that release documentation provided by third party suppliers complies with all required Regulatory standards.

+ Provide final INDV review of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.

+ Assess temperature excursions during shipments according to the SOP.

+ Raise deviations / provide Product Disposition Statements in order to establish and support the disposition of batches for local markets.

+ Assist in providing direction in batch disposition of commercial product manufactured in the US into all authorized markets.

+ Responsible for ensuring inspection readiness internally and at all key suppliers. Support management during inspections by competent authorities.

+ Responsible for vendor assurance of all critical suppliers within the defined supply chain. This includes performing external GMP audits and completing reports in a timely manner.

+ Assist in providing support in internal audit activities for GMP compliance and to identify and raise GMP issues as or if they arise.

+ Ensure that Annual Product Reviews have been completed by responsible third parties and have been assessed internally against requirements and are delivered according to schedule.

+ Ensure that deviations investigations, change management and CAPA activities which support commercial activities meet internal and regulatory requirements.

+ Raise deviations as necessary and contribute to investigations, root cause analysis and CAPA identification on a case-to-case basis.

+ Participate in the review, investigations, and responses for product quality complaints.

+ Participate in New and Existing Product development through the technical transfer process.

+ Participate in the development of Standard Operating Procedures.

+ Work directly with CMO/CPO to gather and report leading and lagging indicators as part of the Quality monthly metrics.

+ Provide support for the development and maintenance of Quality Agreements with third party suppliers and partners.

+ Participate in the development and presentation of GxP training in quality and compliance systems and procedures for new and existing employees.

+ Any other duties as determined by management


**QUALIFICATIONS:**


+ Bachelor of Science degree, minimum, in a relevant scientific discipline.

+ 4+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.

+ Direct experience in reviewing manufacturing and packaging batch records as well as analytical testing results.

+ Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.

+ Strong computer skills including Microsoft platform and Visio.

+ Proficiency in Risk Assessment skills to support deviation investigations, change management and CAPA


\#P2


**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** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-05 Expires: 2022-09-12

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Lead - Product Quality Assurance

Kelly Services
Richmond, VA 23224

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