Quality Assurance Specialist
Palatka, FL Palatka, FL Full-time Full-time $65,000 - $85,000 a year $65,000 - $85,000 a year 22 hours ago 22 hours ago 22 hours ago Quality Control Specialist - Palatka Grow Facility Green Dragon is one of the largest and fastest growing recreational dispensaries in Colorado, with multiple retail stores across the state of Colorado and Florida.
Purpose:
The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation, and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
Reporting Relationship:
The Quality Assurance Specialist will report directly to the Associate Director of Quality Assurance or designee.
Duties and
Responsibilities:
Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently Write, review, and revise standard operating procedures Provide training to laboratory and manufacturing staff on GMP regulations, best practices, and internal requirements Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed Perform in-phase inspections in support of GLP studies, write inspection and QA reports Review and approve Certificates of Analysis and/or Certificates of Test Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations, and investigations Track open observations and Corrective and Preventative Actions (CAPA) to closure Assist with the analysis of trends and metrics to ensure continuous quality improvements Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision Other duties and responsibilities as assigned This job description is subject to change at any time Educational
Qualifications:
Level I - B.
S.
degree in a scientific discipline and no QA experience Level II - B.
S.
degree in a scientific discipline and at least two (2) years' QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company Level III - B.
S.
degree in a scientific discipline and at least five (5) years' QA experience (7 preferred) in a GLP/GMP environment, preferably in a biotechnology company Additional Qualifications In-depth understanding GMP regulations, guidance documents, systems, processes, and procedures Great attention to detail Strong interpersonal skills Strong prioritization, organizational and negotiating skills Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines Must have a Valid Driver's License Physical Requirements / Physical demands:
Medium work (< 50 lbs.
) Physical activity:
lifting, kneeling/crouching, reaching, standing, typing/grasping, walking, pushing/pulling, hearing Visual acuity:
reading, writing, preparing/analyzing data Working conditions:
indoor office environment and lab area Job Type:
Full-time Pay:
$65,000.
00 - $85,000.
00 per year
Benefits:
Dental insurance Employee discount Health insurance Vision insurance Experience level:
5 years Schedule:
8 hour shift Monday to Friday Work setting:
In-person Manufacturing facility Ability to commute/relocate:
Palatka, FL 32177:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Are you 21 years of age or older? Shift availability:
Day Shift (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Purpose:
The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation, and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
Reporting Relationship:
The Quality Assurance Specialist will report directly to the Associate Director of Quality Assurance or designee.
Duties and
Responsibilities:
Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently Write, review, and revise standard operating procedures Provide training to laboratory and manufacturing staff on GMP regulations, best practices, and internal requirements Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed Perform in-phase inspections in support of GLP studies, write inspection and QA reports Review and approve Certificates of Analysis and/or Certificates of Test Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations, and investigations Track open observations and Corrective and Preventative Actions (CAPA) to closure Assist with the analysis of trends and metrics to ensure continuous quality improvements Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision Other duties and responsibilities as assigned This job description is subject to change at any time Educational
Qualifications:
Level I - B.
S.
degree in a scientific discipline and no QA experience Level II - B.
S.
degree in a scientific discipline and at least two (2) years' QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company Level III - B.
S.
degree in a scientific discipline and at least five (5) years' QA experience (7 preferred) in a GLP/GMP environment, preferably in a biotechnology company Additional Qualifications In-depth understanding GMP regulations, guidance documents, systems, processes, and procedures Great attention to detail Strong interpersonal skills Strong prioritization, organizational and negotiating skills Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines Must have a Valid Driver's License Physical Requirements / Physical demands:
Medium work (< 50 lbs.
) Physical activity:
lifting, kneeling/crouching, reaching, standing, typing/grasping, walking, pushing/pulling, hearing Visual acuity:
reading, writing, preparing/analyzing data Working conditions:
indoor office environment and lab area Job Type:
Full-time Pay:
$65,000.
00 - $85,000.
00 per year
Benefits:
Dental insurance Employee discount Health insurance Vision insurance Experience level:
5 years Schedule:
8 hour shift Monday to Friday Work setting:
In-person Manufacturing facility Ability to commute/relocate:
Palatka, FL 32177:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Are you 21 years of age or older? Shift availability:
Day Shift (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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