Overview: This position is responsible for assisting in all validation activities including the development of documentation. This position is also responsible for the set-up, operation, cleaning and maintenance of mechanical equipment utilized in the packaging of clinical supplies. Full-Time daytime hours with a competitive rate of $14/hour.
- Assist in the development of validation related SOPs
- Assist in the development of validation documentation
- Assist in the execution of qualification protocols
- Assist in the development of qualification protocols
- Assist in preventive maintenance and calibration activities
- Assist in the periodic monitoring of validated equipment and systems
- Reviews calibration certificates and files reports in a timely manner
- Executes performance qualifications; may assist in installation and operation qualifications for all types of packaging equipment
- Performs equipment cleaning procedures
- Completes equipment set-up procedures for packaging batch records
- Operates equipment during batch record activities
- Troubleshoots equipment malfunctions
- Performs preventative maintenance on all equipment
- Maintains spare parts inventories
- Other duties as required
- Bachelor’s degree or High school degree /GED with equivalent validation experience
- Interpersonal skills
- Solid reading and writing skills
- Solid communication skills
- Problem-solving skills
- English literacy
- General mathematical skills
- Computer literacy
- Ability to understand and follow directions
- Attention to detail
- Ability to work independently
- Familiarity with cGMPs
- Familiarity with 21 CFR Part 11 regulations
- Understanding of equipment validation concepts and procedures
- Ability to work well with others within and outside of the packaging rooms
- Ability to perform as a packaging room aide
- High degree of electrical, electronic, pneumatic and mechanical skills
General Personal Characteristics of our Employees:
- Strong interpersonal communication skills are that are essential in ensuring good customer relations.
- Demonstrate the ability to organize, and analyze complex and diverse information and use same to resolve problems in a timely manner.
- Pursue training and development opportunities in order to continuously build knowledge and skills.
- Must be willing to share expertise with others.
- Be able to read, understand written and verbal instructions, speak and write clearly in order to communicate effectively.
- Must be able to demonstrate group presentation skills.
- Display openness to others views, must be able to balance team and individual responsibilities.
- Must contribute to building positive team spirit by supporting everyone’s efforts to succeed.
- Show respect and sensitivity for cultural differences and work toward promoting a harassment free environment and diverse workforce.
- Must treat everyone with respect, work with integrity and uphold and support organizational values and goals.
- Follow all organizational policies and procedures.
- Be able to prioritize and plan work activities using time efficiently.
- Must react well under pressure and accept responsibilities for his/her own actions.
- Must respond to management direction.
- Demonstrate accuracy and thoroughness, apply feedback to improve performance and monitor his or her own work to ensure quality.
- Should always be willing to generate suggestions to improve individual and departmental performance.
- Must be punctual at all times and ensure that work responsibilities are covered in his/her absence.
- Must complete tasks correctly and on time.
- May be subject to a background check.
If you meet the requirements for this position, please submit your resume as a Microsoft Word Document attachment to Staffing@perryresources.com
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