Alcami Corporation
Quality Specialist - cGMP Manufacturing - 3rd Shift
Alcami Corporation, Columbia, South Carolina, United States
Overview
Quality Specialist - cGMP Manufacturing - 3rd Shift The Quality Specialist will provide site quality support in a fast-paced environment by performing activities of substantial variety to ensure quality and regulatory compliance. The role is proficient in document and protocol approvals applicable to processes conducted at the respective lab or manufacturing facility, including reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis, and providing quality and compliance training. The position may develop SOPs or other quality documents as needed. On-Site Expectations
100% on-site position. 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am. Responsibilities
Performs quality review and approval of complex documents, data, protocols, and/or reports. Supports quality floor audits and inspections. Supports client and regulatory agency audits and inspections. Provides quality evaluation and release of materials, products, equipment and facilities as required. Maintains quality databases and may perform analysis and trending. Assists with quality improvement initiatives as needed. Develops quality SOPs or other quality documents and/or reports as needed. Provides consultation on complex quality and compliance topics in areas of expertise. Develops and provides training in quality and compliance topics in areas of expertise. Provides Quality oversight for the site-specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc. Performs a variety of complex duties on schedule with accuracy and competency. Maintains accurate files and records. Ensures timely completion and compliance with cGMP and other relevant company training requirements. Other duties as assigned. Qualifications
Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree in relevant field and 1+ years of related experience. Relevant GMP experience required. Experience in Environmental monitoring and critical utilities preferred for sterile operations. Knowledge, Skills, And Abilities
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise. Good written and oral communication skills. Good math skills. Good computer skills and knowledge of Microsoft Office products. Ability to be trained and to mentor. Ability to act independently. Ability to interact well with clients and regulatory agents. Ability to negotiate. Ability to interact well with employees at all levels. Ability to act as technical consultant. Uses professional concepts and company policies and SOPs to solve a variety of problems. Receives minimal instruction on day-to-day work, general instructions on new assignments. Travel
Up to 5% travel required. Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee may need to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to lift and/or move up to 10 pounds regularly, up to 25 pounds frequently, and up to 50 pounds occasionally. Specific vision abilities include close, distance, and peripheral vision. The employee may be exposed to moving mechanical parts, high places and vibration. The noise level is usually quiet; additional lab/manufacturing areas may be louder. PPE may include safety eyewear, respirators, lab coats, gloves, etc. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Quality Specialist - cGMP Manufacturing - 3rd Shift The Quality Specialist will provide site quality support in a fast-paced environment by performing activities of substantial variety to ensure quality and regulatory compliance. The role is proficient in document and protocol approvals applicable to processes conducted at the respective lab or manufacturing facility, including reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis, and providing quality and compliance training. The position may develop SOPs or other quality documents as needed. On-Site Expectations
100% on-site position. 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am. Responsibilities
Performs quality review and approval of complex documents, data, protocols, and/or reports. Supports quality floor audits and inspections. Supports client and regulatory agency audits and inspections. Provides quality evaluation and release of materials, products, equipment and facilities as required. Maintains quality databases and may perform analysis and trending. Assists with quality improvement initiatives as needed. Develops quality SOPs or other quality documents and/or reports as needed. Provides consultation on complex quality and compliance topics in areas of expertise. Develops and provides training in quality and compliance topics in areas of expertise. Provides Quality oversight for the site-specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc. Performs a variety of complex duties on schedule with accuracy and competency. Maintains accurate files and records. Ensures timely completion and compliance with cGMP and other relevant company training requirements. Other duties as assigned. Qualifications
Bachelor’s degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master’s degree in relevant field and 1+ years of related experience. Relevant GMP experience required. Experience in Environmental monitoring and critical utilities preferred for sterile operations. Knowledge, Skills, And Abilities
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise. Good written and oral communication skills. Good math skills. Good computer skills and knowledge of Microsoft Office products. Ability to be trained and to mentor. Ability to act independently. Ability to interact well with clients and regulatory agents. Ability to negotiate. Ability to interact well with employees at all levels. Ability to act as technical consultant. Uses professional concepts and company policies and SOPs to solve a variety of problems. Receives minimal instruction on day-to-day work, general instructions on new assignments. Travel
Up to 5% travel required. Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee may need to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to lift and/or move up to 10 pounds regularly, up to 25 pounds frequently, and up to 50 pounds occasionally. Specific vision abilities include close, distance, and peripheral vision. The employee may be exposed to moving mechanical parts, high places and vibration. The noise level is usually quiet; additional lab/manufacturing areas may be louder. PPE may include safety eyewear, respirators, lab coats, gloves, etc. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr