Randstad USA
job
Summary:
We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company.
Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.
Our Technical Writer/Document Controller willManage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc.
Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11.
Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements.
Create and enhance procedural and operational documentation as required.
We need people whoHave excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation.
Have experience with document control management and related systems.
Exhibit attention to detail and organizational skills.
Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.
).
Understand and are experienced in good documentation practices and ALCOA
principles.
Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.
This role requires a Bachelor's Degree and 3
years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.
location:
Mebane, North Carolinajob type:
Permanentsalary:
$70,000 - 85,000 per yearwork hours:
9am to 6pmeducation:
Bachelors
Responsibilities:
We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company.
Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.
Our Technical Writer/Document Controller willManage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc.
Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11.
Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements.
Create and enhance procedural and operational documentation as required.
We need people whoHave excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation.
Have experience with document control management and related systems.
Exhibit strong attention to detail and organizational skills.
Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.
).
Understand and are experienced in good documentation practices and ALCOA
principles.
Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.
This role requires a Bachelor's Degree and 3
years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.
Qualifications:
Experience level:
ExperiencedMinimum 5 years of experienceEducation:
Bachelors (required) skills:
Documentation Control (3 years of experience is required)quality systems (3 years of experience is required)ALCOA (1 year of experience is required)FDA (3 years of experience is required)pharmAbout the Company:
Randstad USARandstad was founded in 1960 by Frits Goldschmeding.
We've never let go of his passion or the values that he established.
By staying true to those fundamentals, we've expanded to represent more than 90 percent of the HR services market.
We provide outsourcing, staffing, consulting and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing.
We can't wait to tell you all about it.
Our mission is to be a world leader in matching demand for, and supply of, labor and HR services.
We believe in the value of work as a unifying force that shapes society for the better.
We live by the core values established early in our company's history:
to know, serve and trust, striving for perfection and simultaneous promotion of all interests.
Company Size:
10,000 employees or moreIndustry:
Staffing/Employment AgenciesFounded:
1960Website:
https:
//www.
randstadusa.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company.
Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.
Our Technical Writer/Document Controller willManage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc.
Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11.
Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements.
Create and enhance procedural and operational documentation as required.
We need people whoHave excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation.
Have experience with document control management and related systems.
Exhibit attention to detail and organizational skills.
Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.
).
Understand and are experienced in good documentation practices and ALCOA
principles.
Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.
This role requires a Bachelor's Degree and 3
years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.
location:
Mebane, North Carolinajob type:
Permanentsalary:
$70,000 - 85,000 per yearwork hours:
9am to 6pmeducation:
Bachelors
Responsibilities:
We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company.
Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.
Our Technical Writer/Document Controller willManage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc.
Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11.
Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements.
Create and enhance procedural and operational documentation as required.
We need people whoHave excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation.
Have experience with document control management and related systems.
Exhibit strong attention to detail and organizational skills.
Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.
).
Understand and are experienced in good documentation practices and ALCOA
principles.
Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.
This role requires a Bachelor's Degree and 3
years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.
Qualifications:
Experience level:
ExperiencedMinimum 5 years of experienceEducation:
Bachelors (required) skills:
Documentation Control (3 years of experience is required)quality systems (3 years of experience is required)ALCOA (1 year of experience is required)FDA (3 years of experience is required)pharmAbout the Company:
Randstad USARandstad was founded in 1960 by Frits Goldschmeding.
We've never let go of his passion or the values that he established.
By staying true to those fundamentals, we've expanded to represent more than 90 percent of the HR services market.
We provide outsourcing, staffing, consulting and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing.
We can't wait to tell you all about it.
Our mission is to be a world leader in matching demand for, and supply of, labor and HR services.
We believe in the value of work as a unifying force that shapes society for the better.
We live by the core values established early in our company's history:
to know, serve and trust, striving for perfection and simultaneous promotion of all interests.
Company Size:
10,000 employees or moreIndustry:
Staffing/Employment AgenciesFounded:
1960Website:
https:
//www.
randstadusa.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
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