Quality Compliance Coordinator
Morgantown, PA Morgantown, PA Full-time Full-time Estimated:
$55.
5K - $70.
3K a year Estimated:
$55.
5K - $70.
3K a year Come join our Quality team!! PhytogenX is an FDA-regulated and cGMP-compliant manufacturing facility specializing in personal care beauty products.
Committed to our customers' visions, we offer a variety of different processes all designed to make it as easy as possible for them to hit the market with their product.
The Quality Compliance Coordinator will have overall responsibility for ensuring PhytogenX personnel, processes, and equipment comply with current Good Manufacturing Practices (cGMP) as outlined in 21CFR 210 & 211 and ISO 22716.
Liaise with all relevant departments to ascertain current compliance levels Provide training and education to team members regarding cGMP Ensure that all team members are aware of the procedures to be followed to adhere to compliance requirements Organize and conduct internal audits and follow-up on any audit related corrective actions Coordinate external regulatory and customer audits and complete requested self-assessments/questionnaires Organize, perform, and track the environmental monitoring program of the facility Oversee the maintenance and performance of the USP water system Organize, perform, and track IQ/OQ/PQ and validation on all production and quality related equipment Organize and monitor the equipment calibration program Oversee the pest control program Maintain and update FDA product registrations and applicable state manufacturing registrations Coordinate and delegate compliance related tasks for the Compliance Analyst Requirements:
Bachelor's degree in Chemistry, Biology, or other scientific discipline with 3-5 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry Associates degree in Chemistry, Biology, or other scientific discipline with 5-7 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry High School Diploma, or equivalent, with 7
years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry Strong knowledge or understanding of cGMP requirements Strong organizational skills and attention to detail Ability to multitask and adjust priorities Computer skills/MS Office proficiency Good communication skills and an ability to work in a fast-paced environment Job Type:
Full-time
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Ability to commute/relocate:
Morgantown, PA 19543:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Please list your salary requirements
Experience:
compliance:
5 years (Preferred) FDA regulations:
5 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
$55.
5K - $70.
3K a year Estimated:
$55.
5K - $70.
3K a year Come join our Quality team!! PhytogenX is an FDA-regulated and cGMP-compliant manufacturing facility specializing in personal care beauty products.
Committed to our customers' visions, we offer a variety of different processes all designed to make it as easy as possible for them to hit the market with their product.
The Quality Compliance Coordinator will have overall responsibility for ensuring PhytogenX personnel, processes, and equipment comply with current Good Manufacturing Practices (cGMP) as outlined in 21CFR 210 & 211 and ISO 22716.
Liaise with all relevant departments to ascertain current compliance levels Provide training and education to team members regarding cGMP Ensure that all team members are aware of the procedures to be followed to adhere to compliance requirements Organize and conduct internal audits and follow-up on any audit related corrective actions Coordinate external regulatory and customer audits and complete requested self-assessments/questionnaires Organize, perform, and track the environmental monitoring program of the facility Oversee the maintenance and performance of the USP water system Organize, perform, and track IQ/OQ/PQ and validation on all production and quality related equipment Organize and monitor the equipment calibration program Oversee the pest control program Maintain and update FDA product registrations and applicable state manufacturing registrations Coordinate and delegate compliance related tasks for the Compliance Analyst Requirements:
Bachelor's degree in Chemistry, Biology, or other scientific discipline with 3-5 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry Associates degree in Chemistry, Biology, or other scientific discipline with 5-7 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry High School Diploma, or equivalent, with 7
years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry Strong knowledge or understanding of cGMP requirements Strong organizational skills and attention to detail Ability to multitask and adjust priorities Computer skills/MS Office proficiency Good communication skills and an ability to work in a fast-paced environment Job Type:
Full-time
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Ability to commute/relocate:
Morgantown, PA 19543:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Please list your salary requirements
Experience:
compliance:
5 years (Preferred) FDA regulations:
5 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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