Gap Certificate Required Documents Jobs in Usa
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Role – Technical Writer (Engineering)
Salary – $75,000+ per annum
Type – Full-time, Permanent
Location – St. Petersburg, FL
A leading manufacturer of automated packaging equipment is looking to hire a technically capable Technical Writerto support the creation and management of machine documentation. This role is ideal for someone with an engineering or manufacturing background who can confidently interpret technical information and produce clear, structured documentation for both internal teams and end users.
The Technical Writer will work closely with engineering and production teams to ensure all manuals and supporting materials accurately reflect machine design, operation, and maintenance requirements.
The Technical Writer will have the following attributes:
- Degree in Engineering, Technical Communication, Industrial Technology, or a related field; alternatively, equivalent hands-on experience within manufacturing or technical documentation.
- Experience producing documentation within an industrial or machinery-based environment.
- Ability to read and interpret engineering drawings, BOMs, and assembly documentation.
- Proficiency with SolidWorks or similar CAD platforms.
- Strong working knowledge of Microsoft Office, particularly Word.
- Clear written communication skills with strong attention to detail.
- Organized and capable of managing multiple documentation projects simultaneously.
- Spanish language skills are beneficial but not essential.
The Technical Writer's role will involve:
- Producing and maintaining machine manuals covering installation, operation, and servicing.
- Generating parts lists and structured technical content from engineering documentation.
- Supporting internal departments with work instructions and procedural documentation.
- Updating materials to reflect product changes and continuous improvement initiatives.
- Spending time on the production floor to review equipment and validate documentation accuracy.
For more information about this Technical Writer opportunity, please apply, or email Jack Smillie at for further details.
Many thanks,
Premier Group
The Paralegal will support attorneys by assisting with legal document preparation, case file management, and litigation support activities. This role is heavily focused on drafting pleadings and assembling court filings in a fast-paced legal environment.
Duties & Responsibilities
- Draft, review, and prepare legal documents including pleadings, motions, affidavits, notices, and supporting filings.
- Assist attorneys with preparation of litigation materials and court filings in accordance with applicable court rules and procedures.
- Assemble and organize case packages and supporting documentation for court submissions and hearings.
- Review case files to ensure accuracy, completeness, and compliance with procedural requirements.
- Maintain and organize case files, pleadings, exhibits, and supporting documents within the firm’s case management system.
- Coordinate with attorneys and internal teams to track case progress and ensure deadlines are met.
- Conduct basic legal research and review statutes, regulations, and case law as requested.
- Support attorneys with other litigation-related tasks and administrative functions as needed.
Qualifications
- Strong written communication skills with the ability to draft and review legal documents.
- Understanding of legal terminology, court pleadings, and filing procedures.
- Strong attention to detail and organizational skills.
- Ability to manage multiple deadlines in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Ability to maintain confidentiality and exercise sound judgment.
- Proficiency with Microsoft Office and case management systems.
Education & Experience
- Associate degree in Paralegal Studies or related field preferred.
- 2+ years of experience in a legal support or paralegal role with exposure to drafting pleadings or litigation documents preferred.
Are you ready to put your clerical skills to work in a fast-paced, rewarding environment? Our client is looking for a Document Clerk to join their dynamic team. This is a long-term opportunity with steady hours, a supportive team, and room to grow.
WHY YOU'LL LOVE THIS ROLE:
- Be a key part of a team that keeps operations running smoothly – your attention to detail makes a real impact.
- Work in a secure, professional environment in the technology and automotive services industry.
- Enjoy a consistent Monday–Friday schedule with a competitive pay rate
LOCATION: Sacramento, CA.
SALARY: $19.25/hr.
SCHEDULE: Monday – Friday | Day/Swing Shift available: 8:00 am – 4:30 pm & 1:00 pm – 9:30 pm | Long-term
INDUSTRY: Technology and Automotive Services
THE ROLE
As a Document Clerk, you'll manage important documents with speed and accuracy, ensuring smooth workflow between departments. You'll perform tasks such as receiving, scanning, batching, validating, and maintaining daily document operations.
KEY RESPONSIBILITIES:
- Scan and validate documents to ensure clarity and accuracy.
- Correct and verify data fields to match scanned documents.
- Perform daily maintenance on scanning equipment.
- Conduct research and data entry for account activities.
WHAT WE'RE LOOKING FOR:
- Strong knowledge of Microsoft Word, Excel, and PowerPoint.
- Accurate and efficient data entry skills (45+ WPM).
- High School Diploma or GED required.
- Experience with DMV Title Processing is a plus.
DIVERSITY, EQUITY, AND INCLUSION STATEMENT
We are committed to fostering an inclusive workplace that welcomes diverse candidates. All qualified applicants will be considered regardless of background, identity, or status.
This position is offered through the Sacramento Branch of NW Staffing Resources. When applying through , please click "Apply Here" and select the Sacramento Branch for immediate consideration. Or contact our office directly at 916-993-4182 to speak with a Recruiter.
For more information regarding our company and employee benefits, please click on the links below.
About NW Staffing Resources
NW Staffing Employee Benefits
For more information regarding the CCPA California Consumer Privacy Act, and the data we store, please CLICK HERE to review before you apply.
Williams Lea by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary for this role at the noted RRD location is $17.25 / hour. Starting pay decisions
are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Williams Lea, by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly.
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary for this role at the noted RRD location is $16.95-17.50 / hour. Starting pay decisions are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Williams Lea by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly.
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner.
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary for this role at the noted RRD location is $17.40-17.75/ hour. Starting pay decisions are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Williams Lea by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary for this role at the noted RRD location is $17.50 / hour. Starting pay decisions are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Williams Lea by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly.
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary range for this role at the noted RRD location is $16.50- $17.50 / hour. Starting pay decisions
are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Williams Lea by RRD is a global business support services company with a strong legacy—over 200 years of experience delivering world-class business solutions. We specialize in delivering skilled administrative support, document production, presentation design, and marketing and communications services to leading companies around the world—especially within legal, financial, and professional services industries.
We’re a people-powered organization. With a presence in North America, the UK, Europe, and Asia Pacific, we have thousands of employees globally, all working together to help our clients operate more efficiently and effectively. Whether it’s supporting law firms with critical document production or helping financial institutions manage high-volume print and digital communications, we’re the behind-the-scenes team making everything run smoothly.
The Document Production Associate position is responsible for providing word processing and/or document production services for our clients.
(* denotes an “essential function”)
- *Utilize appropriate logs and/or tracking software for all document production work
- *Thoroughly assess job request and ensure appropriate completion of job tasks throughout task lifecycle
- *Perform work in document production, proofreading, intake and workflow coordination functions, as needed
- *Use established procedures, standards and formats to edit, proof, convert, create, transcribe or otherwise complete document production requests to client satisfaction
- *Demonstrate proficiency in using equipment/technology/software and hardware necessary to perform job functions
- *Communicate with team members, lead, supervisor or client on job or deadline concerns
- *Meet contracted deadlines for service delivery to our clients
- *Troubleshoot basic software or hardware problems
- Help to foster a proactive environment of continuous service enhancement and relationship building with the client
- Perform quality assurance on work, as requested
- Adhere to Williams Lea Tag policies, in addition to client policies
- Use equipment and supplies in a cost efficient manner
- High school diploma or equivalent
- Minimum (1) year document production experience preferably in a legal, banking or large corporate environment
- Skilled in the use MS Office software (Word, Excel, PowerPoint); strong keyboarding and typing skills
- Familiar with other software programs for editing and/or creating documents
- Strong attention to detail; able to work on multiple projects simultaneously
- Must have good organizational skills
- Must be able to meet deadlines and complete all projects in a timely manner
- Ability to handle sensitive and/or confidential documents and information
- Able to exercise good judgment to make decisions that conform to business needs and policy
- Good problem solving skills, with the ability and understanding of when to escalate a problem to a supervisory level
- Ability to maintain professional composure when working with immediate deadlines
- Ability to work both independently and collaboratively as part of a team
- Ability to work in a fast paced environment
- Ability to communicate professionally both verbally and in writing
- Must be self-motivated with a positive attitude
- Proven customer service skills are required in order to create, maintain and enhance customer relationships
The salary range for this role at the noted RRD location is $16.5-17.5 / hour. Starting pay decisions
are determined based on multiple factors including but not limited to relevant education, qualifications,
skills, experience, certifications, proficiency, performance, shift, location, and other business
needs. Typically, roles follow step progressions to a target rate or set increments over time. Depending on
the role, in addition to the hourly rate of pay, the total compensation package may also include overtime, shift differential, call-in, and/or stand-by pay. RRD’s benefit offerings include
medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with company match, life
insurance and other voluntary supplemental insurance coverages, plus parental leave, adoption
assistance, tuition assistance and employer/partner discounts.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer, including disability/veterans
Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary:
$80-90k
Overview:
In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.
Schedule:
Monday-Friday, standard working hours
Responsibilities:
- Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.
- Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.
- Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.
- Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.
- Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.
- Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.
- Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).
- Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.
- Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.
- Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.
Qualifications:
- Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred.
- 8+ years of QA experience in a GMP-regulated environment.
- 3+ years of people management experience.
- Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.
- Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.
- Proven experience supporting successful regulatory inspections and customer audits.
- Superior project management, change leadership, and communication skills.
