Careers

Overview

Cyanta Analytical Services, an independent pharmaceutical testing laboratory located in Maryland Heights, Missouri, is seeking to fulfill a Chemist position for analytical research and development. Applicant must be responsible to operate and maintain laboratory and non-laboratory instruments, generate experimental data according to written SOP, protocol, method, or work instructions, and accordance to cGMP guidelines.

Responsibilities include: technical expertise, projects and customer interactions when requested, communication, and organization. A minimum of an Associates Degree in chemistry and 2+ years of applicable experience, or a Bachelor's Degree and 0-2 years of applicable experience. Additional responsibilities will include project management, experience with routine laboratory instrumentation.

The candidate should be highly motivated, posses excellent interpersonal skills, and enjoy working in a team oriented, entrepreneurial company. Cyanta offers a competitive compensation package including health, dental, and life insurance, 401(k) plan, short and long term disability, Section 125, and vacation time. This position needs to be filled as soon as possible. Please send resume to Human Resources by e-mail, hr@chemir.com or fax to (314) 227-0860.

Overview

Quality Assurance Manager

Job Description
Manage work of the Quality Assurance Unit (QAU) in accordance with cGMP and internal Standard Operating Procedures (SOP's).

Responsibilities
Oversee all of the Quality Assurance functions including:

• Maintenance of SOP program
• Auditing, approval or rejection or SOP's, standard testing procedures, stability records, and deviations from written procedures.
• Auditing, approval or rejection of instrument installation, Operation, and Performance Qualification (IQ/OQ/PQ) documentation.
• Auditing, approval or rejection of analysis reports, methods transfer reports, method validation reports, and stability study reports.
• Oversee the QA data auditors and QA Documentation Specialist functions.
• Conduct external audits as needed.

Ensure personnel compliance with cGMP and other applicable regulations; identify compliance issues and communicate problems to management that might affect laboratory operations.

Trend all OOS investigations as well as nonconformance issues quarterly and report to the Associated Director of Quality Assurance.

Evaluate Laboratory Investigation Reports (LIR's) against laboratory results and documentation.

Administer the Corrective Action/Preventive Action (CAPA) program and ensure its effectiveness.

Author, approve or reject responses to customer audits, representing Quality Assurance on project teams.

Substitute as company interface to the Food and Drug Administration (FDA) and other groups conducting audits of the company as necessary.

Conduct Current Good Manufacturing Practices (CGMP) training sessions; periodically Audit Personnel Training Files.

Qualifications
Demonstrated familiarity with at least two scientific techniques (HPLC, GC, etc.)

At least 2-5 years experience working in a Quality Assurance/Quality Control role within a cGMP environment.

Company offers a competitive compensation package including health, dental, and life insurance, short-term and long-term disability, Section 125, and vacation time. Please send resume to Human Resources by e-mail, hr@chemir.com or fax to (314) 227-0860.

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