Facilities Documentation Control Specialist

Summarized Purpose:

The Documentation Control Specialist provides various documentation writing and editing functions to the facilities Project Design Team. The ability to work on a team, as well as independently, while maintaining clear communication and accurate documentation skills is key to this role!

Company Overview:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

Essential Functions Performs the change control documentation process within Facilities Project Design Team. QA Audit Findings resolution. Manages Issued For Construction and As Built drawing documentation filing. Submits Purchase Requisitions and follows up on PO Approval. Assists in developing IQ/OQ/PQs with Project Lead. Assembles Validation Summary Binders. Coordinates and performs multiple facilities support services which may include conference room scheduling and setup, employee moves, and travel arrangements. Coordinates assigned activities with outside contractors and vendors, as needed. Makes recommendations for improving procedures and developing templates. Responds to facility related emergencies, as assigned. May cross-train or mentor department staff. Performs all other duties as assigned by location.

What to Expect Next:

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Once your application is submitted, check out the link below to earn more about our Middleton, WI site! https://www.ppdi.com/Services/Laboratories/cGMP-Lab-Testing

Summarized Purpose:

The Documentation Control Specialist provides various documentation writing and editing functions to the facilities Project Design Team. The ability to work on a team, as well as independently, while maintaining clear communication and accurate documentation skills is key to this role!

Company Overview:

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health!

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

Essential Functions Performs the change control documentation process within Facilities Project Design Team. QA Audit Findings resolution. Manages Issued For Construction and As Built drawing documentation filing. Submits Purchase Requisitions and follows up on PO Approval. Assists in developing IQ/OQ/PQs with Project Lead. Assembles Validation Summary Binders. Coordinates and performs multiple facilities support services which may include conference room scheduling and setup, employee moves, and travel arrangements. Coordinates assigned activities with outside contractors and vendors, as needed. Makes recommendations for improving procedures and developing templates. Responds to facility related emergencies, as assigned. May cross-train or mentor department staff. Performs all other duties as assigned by location.

What to Expect Next:

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Once your application is submitted, check out the link below to earn more about our Middleton, WI site! https://www.ppdi.com/Services/Laboratories/cGMP-Lab-Testing

Qualifications:

Education and Experience:

· High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Technical positions may require a certificate.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4years) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities:

· Ability to handle multiple projects and balance priorities.

· Positive attitude and the ability to interact effectively with others.

· Excellent oral and written communication skills.

· Strong computer skills, including Microsoft Office.

· Strong problem solving skills.

· May require knowledge of building systems including, but not limited to, HVAC, plumbing, electrical, and controls.

· May require knowledge and understanding of computerized maintenance and work order systems.

· May require a good understanding of security systems.

Management Role: No management responsibility

Working Conditions and Environment:

· Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.

· May occasionally drive to site locations.

· Potential Occasional travel required.

· Physical Requirements:

· Frequent mobility required.

· May be stationary for 4-6 hours per day.

· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

· Frequent crouching, stooping, bending and twisting of upper body and neck.

· Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and laptop computer, with a maximum lift of 25 lbs. required frequently.

· Lifting / carrying objects of 26-50 lbs. required occasionally.

· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

· Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

· May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

· Works with guidance or reliance on oral or written instructions from management.

· May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

· Ability to perform under stress.

· Ability to multi-task.

· Regular and consistent attendance.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Qualifications:

Education and Experience:

· High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

Technical positions may require a certificate.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4years) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities:

· Ability to handle multiple projects and balance priorities.

· Positive attitude and the ability to interact effectively with others.

· Excellent oral and written communication skills.

· Strong computer skills, including Microsoft Office.

· Strong problem solving skills.

· May require knowledge of building systems including, but not limited to, HVAC, plumbing, electrical, and controls.

· May require knowledge and understanding of computerized maintenance and work order systems.

· May require a good understanding of security systems.

Management Role: No management responsibility

Working Conditions and Environment:

· Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.

· May occasionally drive to site locations.

· Potential Occasional travel required.

· Physical Requirements:

· Frequent mobility required.

· May be stationary for 4-6 hours per day.

· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

· Frequent crouching, stooping, bending and twisting of upper body and neck.

· Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and laptop computer, with a maximum lift of 25 lbs. required frequently.

· Lifting / carrying objects of 26-50 lbs. required occasionally.

· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

· Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

· May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

· Works with guidance or reliance on oral or written instructions from management.

· May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

· Ability to perform under stress.

· Ability to multi-task.

· Regular and consistent attendance.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.