Primary Objective of Position
The QA Associate II will be responsible for a product line(s) as assigned by the manager. This includes responsibility for the release of materials in accordance with cGMPs and Standard Operating Procedures, review of validation documents, change controls, procedures and other documents related to their assigned product line(s).
Major Duties/Responsibilities
- Independently review and release materials associated with their product line(s) or with other product line(s) when needed as back-up.
Review and approve deviations and investigations for acceptability.
- Prepare and/or approve Certificate of Analysis and Certificate of Conformance.
- Participate in data gathering for reports, investigations. Input information into data bases. Trend and evaluate information for small projects. Prepare technical reports based on their findings.
- Review stability data and experimental/engineering batches.
- Review and approve or write procedures / course plans / specifications and other documents where appropriate.
- Prepare and present training to the QA group for classes attended
- Performs other activities related to Quality Assurance as directed by management.
- Knowledge of parenteral, oral solid dose manufacturing and Environmental Monitoring.
- Regular and reliable attendance on a full-time basis.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies Societal’s cultural values and aligns daily actions with department and company culture.
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Minimum Job Qualifications
Education: Bachelor’s degree in scientific field
Experience: Minimum of three (3) years’ experience in Quality Control, Quality Assurance, or pharmaceutical manufacturing is required. Experience in writing technical reports is required. Experienced in current Good Manufacturing Practices and familiar with simple statistics such as 3 sigma control limits, standard deviation, etc is required.
Knowledge/Skills/Abilities
- Strong analytical skills, with an ability to use logic and simple statistical concepts to identify potential problems and trends.
- Good project management skills
- Strong computer skills and knowledge of word processing software and spreadsheet software
- Knowledge of pharmaceutical industry guidelines, trends and practices
- Act with professionalism and treat others with respect and consideration regardless of their status or position
- This position interacts with a wide variety of topics and personnel and must be able to gather information from multiple sources and coordinate and analyze their impact on each other.
- Previous training in cGMP content is highly preferred.
- Competent in pharmaceutical compliance and regulatory policies
- Microbiology and Clean Room technology
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described here 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 essential functions.
Physical Demands: While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is frequently required to stand and talk or hear; walk or sit; balance, stoop, kneel, crouch or crawl. The employee is occasionally required to push, pull and lift various pieces of equipment. The employee must occasionally lift and/or move up to 50 pounds (drums). Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements.
Mental Demands: While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software. The employee is regularly required to apply mathematical formulae.
Work Environment: The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate.
Special Working Conditions: Travel - 10% based on experience – for training and assistance in auditing.
New hires will pass a background check, drug screen, and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.
We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.
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