Quality Assurance Specialist

Summary

Pace Analytical Life Sciences, LLC is a premier Contract Research and Development Organization located in San Diego, CA, providing pharmaceutical development services for small molecules, biologics, oligonucleotide therapeutics, and other biopharmaceutical drug candidates.

Primary Responsibilities:

• Review and approve manufacturing and packaging batch records in accordance with company policies and Current Good Manufacturing Practices (CGMP’s)
• Prepares or assists in writing, reviewing, approving, and implementing standard operating procedures (SOP’s)
• Oversees manufacturing and labeling activities and performs quality oversight activities such as line clearance
• Initiate and review proper change control, deviation, out of specification and investigation documentation when required
• Review instrument qualification and analytical method validation protocols and reports
• Update pertinent logs and tracking systems as they relate to the company's Quality Systems Document Control

• B.S. degree in Life Sciences or related field is a plus and/or equivalent training or work experience
• Previous experience (1-2 years) working in a Pharmaceutical QA environment reviewing batch records and developing/implementing SOP’s highly preferred
• Knowledge of various regulatory systems and guidelines (FDA and EU GMP's, etc.)
• Must be detail oriented, organized, and possess the ability to be flexible to meet the needs of technical employees across multiple departments
• Ability to work independently or as part of a team
• Must possess strong interpersonal skills and have the proven ability to communicate with employees/customers/clients in both oral and written form, fluent in the English language
• Willingness to learn and expand their knowledge and technical expertise in a fast-paced environment
• Strong computer skills; emphasis on Microsoft Excel and Word

Physical/Mental Requirements:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:
Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors and related items in a lab setting.

OFCCP Statement: Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, and individuals with disabilities, sexual orientation, or gender identity.

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