QC Technical Documentation Specialist I

Use Your Power for Purpose

Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture rooted in science and risk-based compliance is both flexible and innovative always putting the customer first. Whether you are engaged in development maintenance compliance or research analysis your role is crucial in directly impacting patients lives. Your contributions ensure that our high standards are met fostering a culture that is both adaptable and forward-thinking. Every task you undertake every project you contribute to plays a vital part in our mission to provide top-quality care and products to those who need them most.

What You Will Achieve

In this role you will:

• Prepare review and maintain essential documentation including Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) manuals.

• Create and edit procedure manuals quality control manuals engineering documents manufacturing instructions and change authorizations in compliance with company policies and government regulations.

• Implement and manage documentation systems propose change control processes and coordinate the review and approval of procedures and forms.

• Provide input on quality control procedures and R&D documentation and act as an advisor to colleagues due to extensive knowledge and skills.

• Identify innovative solutions to problems taking a broader perspective that benefits the organization and foster collaboration and communication within the team and across groups.

• Train and guide team members helping achieve the goal of delivering the best healthcare to patients and manage your own time and professional development while allocating tasks to others.

• Act as the go-to person for key areas of administrative expertise and execution and route various documents through the Document Management System (DMS) for necessary reviews and approvals.

• Process documentation for effective dating as directed by your supervisor and handle the creation distribution retrieval and storage of production logbooks.

• Maintain the filing system within the Documentation department review and approve documents in the change control system and initiate and facilitate change requests in the Quality Management System (QMS) and PDOCS.

• Adhere to all plant safety rules follow standard operating procedures (SOPs) and training course plans (TCPs) and ensure you stay current with all training requirements.

Here Is What You Need (Minimum Requirements)

• High School Diploma and 6 years experience in a controlled document management/records management position

• An Associates degree with 2 to 4 years experience in a controlled document management/records management position required.

• Or a Bachelors degree with 0 to 2 years experience in a controlled document management/records management position required.

• Thorough knowledge of cGMP and cGDP

• Proficient in QTS and PDOCS

• Proficient in Microsoft Office (Word Excel Powerpoint)

• Ability to work independently and multi-task in a fast priority switching environment while demonstrating a positive attitude

• Strong attention to detail and excellent written and verbal communication skills

• Strong reading comprehension and proof reading skills strong organizational skills

• Strong collaboration and communication skills

• Demonstrated ability to work/contribute in a team-based environment

• Team and customer oriented

• Ability to facilitate process improvements

Bonus Points If You Have (Preferred Requirements)

• Advanced computer skills

• Experience with change control systems

• Ability to train and guide team members

PHYSICAL/MENTAL REQUIREMENTS

Sit for up to 8 hours walking climbing stairs responding to visual warning indicators respond to audible warning indicators respond to color or special visual indicators wear specialized protective clothing as needed (lab coat safety glasses gloves face shield/goggles apron) repetitive use of upper extremities.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives

OTHER JOB DETAILS

Last Date to Apply for Job: Nov 6 2025.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

Work Location Assignment:Hybrid

Relocation assistance may be available based on business needs and/or eligibility.