A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people.

Under the direction of the Quality Manager, the QA Specialist II will assist with the overall development, implementation, and management of the Quality Management System (QMS). The ideal candidate will ensure standard operating procedures are written and implemented in compliance with the Company’s policies, government regulations and industry best practices.

Your key responsibilities

Quality Operation 

• Devise the company's quality procedures, standards and specifications. 
• Develop and maintain QA procedures and programs complementary to corporate objectives and policies.
• Oversee the monitoring, measurement, and review of internal processes, especially those that affect the quality of the company’s services (Change Control, CAPA, internal audits, Management Review, etc.)
• Oversee the implementation of new SOP’s.
• Coordinate the review of existing SOP’s to ensure they are up to date and strictly followed.
• Recommend and facilitate corrective action and preventative action.
• Perform internal facility and system audits on an ongoing basis.
• Participate in external audits involving customers and regulatory agencies.
• Evaluate and recommend alternative auditing procedures for continuous improvement.
• Assist the Quality Department in the implementation of ISO 17025 accreditation.

Report to Management on company performance including deficiencies, deviations, or the need for improvement. 

Assist the Quality Manager with other QA duties as needed.

Skills, knowledge and abilities

• Minimum of 5 years of quality assurance experience, preferably in a laboratory or pharmaceutical field.
• B.Sc./M.Sc. in Chemistry or a Science related field, with knowledge of common laboratory techniques.
• Excellent working knowledge of cGMP/GLP, ICH, USP/NF, ISO 17025 and FDA regulations.
• Excellent communications skills; fluent English (oral & written) required.
• Excellent time management and organizational skills.
• Able to work independently and successfully function in a fast-paced environment.
• Knowledge of Microsoft Office (Word, Excel, Outlook) required.

What’s in it for you …

We invest time and resources into making sure Medisca is as good as the people we hire.

• Balance Your Life – PTO, vacation policy and paid statutory holidays
• Invest in your health – Group Benefit plan and health savings account
• Your Future is Bright – Opportunities to learn and grow within CED
• Save for your Future – 401k plan retirement
• Help us grow – Employee Referral Program
• We like to have fun – company events throughout the year

We invest time and resources into making sure Medisca is as good as the people we hire.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.

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