Quality Assurance Group Leader- On Site Only
2.
7 Brevard, NC Brevard, NC Full-time Full-time From $85,000 a year From $85,000 a year 22 hours ago 22 hours ago 22 hours ago Job Location:
Brevard, NC (on-site only with relocation assistance , NOT A REMOTE WORK POSITION) Raybow USA is the US headquarters for Raybow, a global CDMO.
The Quality Assurance (QA) Group Leader's primary duty is to oversee GMP activities and maintain quality systems in compliance with current regulatory standards for an Active Pharmaceutical Ingredients (API) manufacturing facility.
This is a permanent, full time position located in Brevard, NC.
Requirements - Quality Assurance Group Leader Bachelor or Master degree preferred 10
years experience pharmaceutical, GMP, ISO or other regulated industry OR 5 to 9 years experience with Master degree and demonstrated excellence in role with justification Responsibilities and Duties - Quality Assurance Group Leader Lead a team of quality professionals with differing responsibilities Maintain quality system in accordance with 21 CFR Part 211, ICH Q7A and other regulatory requirements Conduct internal, vendor, client, and/or regulatory audits Review and approve SOPs, protocols and analytical methods for compliance Execute quality tasks (pre-approving instructions, reviewing documentation of executed instructions and production batch records, reporting metrics, document drafting) Review and approval of document change requests Provide direction for and reviewing and approving deviations, corrective and preventive actions, and risk assessments Review resolution and effectiveness of corrective actions and audit responses Assure proper equipment/instrument qualification and validation activities are performed.
Benefits Package Health/Dental/Vision/Long-term Disability Vacation Matching 401K Retirement Program Relocation Package PLEASE PROVIDE RESUME IN WORD OR PDF FORMAT AND STATE CITIZENSHIP/VISA STATUS CLEARLY.
WE DO NOT SPONSOR VISA APPLICATIONS.
Raybow USA (Brevard, NC), a division of Raybow, is a CDMO that conducts contract research and development in organic and medicinal chemistry.
We also provide custom synthesis of commercial and CTM API's (Active Pharmaceutical Ingredients for use in Clinical Trials) manufactured under cGMP conditions.
Raybow is a global provider of outsourced pharmaceutical development and manufacturing services, from preclinical through commercial, for biotechnology and big pharma clients.
The company was founded in 2008 and is headquartered in Taizhou, China.
It employs more than 1,800 people worldwide.
In 2019 Raybow Pharmaceuticals acquired PharmAgra Labs, which was founded in 1998 as a privately held custom synthesis company.
The 14,400 sq.
ft Brevard, NC facility is comprised of research, development, and analytical labs as well as a four bay pilot plant.
The company of about 30 employees is situated on 3.
5 acres located in Transylvania County, North Carolina.
This western NC mountain county is well known for numerous outdoor recreational attractions (60% of the county is state and national forest), an excellent school system and an excellent quality of life.
Job Type:
Full-time Pay:
From $85,000.
00 per year
Benefits:
401(k) matching Dental insurance Health insurance Life insurance Paid time off Parental leave Relocation assistance Vision insurance Schedule:
8 hour shift Monday to Friday Supplemental pay types:
Bonus opportunities Application Question(s):
If offered a position, are you willing to move to Brevard, NC?
Experience:
Pharmaceutical Quality Assurance:
5 years (Required) Language:
fluent english (Required) Ability to Relocate:
Brevard, NC 28712:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
7 Brevard, NC Brevard, NC Full-time Full-time From $85,000 a year From $85,000 a year 22 hours ago 22 hours ago 22 hours ago Job Location:
Brevard, NC (on-site only with relocation assistance , NOT A REMOTE WORK POSITION) Raybow USA is the US headquarters for Raybow, a global CDMO.
The Quality Assurance (QA) Group Leader's primary duty is to oversee GMP activities and maintain quality systems in compliance with current regulatory standards for an Active Pharmaceutical Ingredients (API) manufacturing facility.
This is a permanent, full time position located in Brevard, NC.
Requirements - Quality Assurance Group Leader Bachelor or Master degree preferred 10
years experience pharmaceutical, GMP, ISO or other regulated industry OR 5 to 9 years experience with Master degree and demonstrated excellence in role with justification Responsibilities and Duties - Quality Assurance Group Leader Lead a team of quality professionals with differing responsibilities Maintain quality system in accordance with 21 CFR Part 211, ICH Q7A and other regulatory requirements Conduct internal, vendor, client, and/or regulatory audits Review and approve SOPs, protocols and analytical methods for compliance Execute quality tasks (pre-approving instructions, reviewing documentation of executed instructions and production batch records, reporting metrics, document drafting) Review and approval of document change requests Provide direction for and reviewing and approving deviations, corrective and preventive actions, and risk assessments Review resolution and effectiveness of corrective actions and audit responses Assure proper equipment/instrument qualification and validation activities are performed.
Benefits Package Health/Dental/Vision/Long-term Disability Vacation Matching 401K Retirement Program Relocation Package PLEASE PROVIDE RESUME IN WORD OR PDF FORMAT AND STATE CITIZENSHIP/VISA STATUS CLEARLY.
WE DO NOT SPONSOR VISA APPLICATIONS.
Raybow USA (Brevard, NC), a division of Raybow, is a CDMO that conducts contract research and development in organic and medicinal chemistry.
We also provide custom synthesis of commercial and CTM API's (Active Pharmaceutical Ingredients for use in Clinical Trials) manufactured under cGMP conditions.
Raybow is a global provider of outsourced pharmaceutical development and manufacturing services, from preclinical through commercial, for biotechnology and big pharma clients.
The company was founded in 2008 and is headquartered in Taizhou, China.
It employs more than 1,800 people worldwide.
In 2019 Raybow Pharmaceuticals acquired PharmAgra Labs, which was founded in 1998 as a privately held custom synthesis company.
The 14,400 sq.
ft Brevard, NC facility is comprised of research, development, and analytical labs as well as a four bay pilot plant.
The company of about 30 employees is situated on 3.
5 acres located in Transylvania County, North Carolina.
This western NC mountain county is well known for numerous outdoor recreational attractions (60% of the county is state and national forest), an excellent school system and an excellent quality of life.
Job Type:
Full-time Pay:
From $85,000.
00 per year
Benefits:
401(k) matching Dental insurance Health insurance Life insurance Paid time off Parental leave Relocation assistance Vision insurance Schedule:
8 hour shift Monday to Friday Supplemental pay types:
Bonus opportunities Application Question(s):
If offered a position, are you willing to move to Brevard, NC?
Experience:
Pharmaceutical Quality Assurance:
5 years (Required) Language:
fluent english (Required) Ability to Relocate:
Brevard, NC 28712:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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