QA Document Control Specialist II

Nature and Scope

To perform maintain and update logs and databases. Create and maintain controlled templates. Support document formatting.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Perform assigned controlled document lifecycle and records management processes in Veeva Document Management process.
• Manage proactive review program.
• Update and maintain logs and databases.
• Edit technical documents in accordance with formatting and template requirements.
• Writing and maintaining document control procedures and participating in the development and roll-out of document control tools.
• Scan archive manage controlled documents.
• Print and issue labels for production.
• Contribute to the development of training and deliver training as needed.
• Write basic functional area SOPs.
• Archive and retrieve records as needed.
• Issue controlled documents.
• Create and issue/archive logbooks and notebooks as needed.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Bachelors Degree or equivalent experience required.
• 3 years of experience in cGMP controlled or other regulated environment required.
• 3 years in Pharmaceutical/Medical Device preferred.
• GMP documentation management experience required.
• Proficient use of Microsoft Office.
• Experience with Good Documentation Practices (GDP) and other applicable regulatory requirements.
• Strong organizational skills.
• Team and Customer Oriented.
• Experience with document management/records management software solutions.
• Experience using SharePoint and other business tools.
• Ability to work independently and multi-task in a fast priority-switching environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures maintenance schedules and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.
• This job operates in a professional office environment.
• This role routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines.
• A large portion of the work will be performed in the plant where the noise may be loud.

Expected Salary Range:

$38.41-41.00

The hourly range is the minimum and maximum hourly range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications education knowledge skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare life insurance profit sharing paid time off matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()

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