Sr. QC Technical Documentation Specialist

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).

• 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)

• Minimum of 5 years’ experience in a science/technical related position, pharmaceutical industry preferred.

• 3 years’ experience in a manufacturing site.

• 3 or more years in a pharmaceutical facility.

• Excellent verbal and written communication skills and attention to detail.

• Proficient with Microsoft Office.

• Experience in SAP, QTS, DMS, PDOC system and Change Control preferred

• Experience with Compendial Monographs and General Chapters

• Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.

• Demonstrated ability to write logically and consistently.

• Strong critical thinking and problem solving skills.

• Resourceful and innovative approach.

• Ability to work cross-functionally with a diverse team.

Bonus Points If You Have (Preferred Requirements)

• Advanced computer skills

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

• Strong reading comprehension and proofreading skills

• Experience with change control systems

• Ability to train and guide team members

• Strong collaboration and communication skills

PHYSICAL/MENTAL REQUIREMENTS

Stand up for up to 8 hours, 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 (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.

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