Sequence Inc. is a total quality solutions provider to the Pharmaceutical, Biotech, and Medical Device industries. United with our clients, we strive to provide services that result in deliverables of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry-wide. We specialize in providing excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Qualification and Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.
At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless, humble Attitude creates a respectful environment where ideas are shared and valued. Our teams possess the technical proficiency to do the work and the Aptitude to continue learning, growing and stretching their potential. Our unstoppable Initiative and willingness to get things done using new ideas grow our capabilities and drives our future achievements.
We are currently looking for a Document Control Specialist at a Mid-Senior Level for our Manufacturing Systems Compliance (MSC) Division. Candidates should possess excellence in communication and organization, strong attention to detail, and a willingness to travel to various client sites throughout the Greater Raleigh-Durham Area with future potential for project work out-of-state.
Essential Functions and Responsibilities:
- Work alongside Sequence team members and respond accordingly to client deadlines
- Work with client staff to accomplish goals and meet deadlines
- Develop relationships with co-workers and clients to enhance the efficiency and flow of the project
- Create, revise and maintain company standard operating procedures (SOPs) as required
- Format, track, and issue controlled cGMP documents including protocols, test records, and forms
- Assist in the review of cGMP-controlled documents as necessary
- Issuance of batch production records, tracking of master batch records, tracking of all batch production records and lot number issuance
- Maintain validation files (validation protocols, validation summary reports, engineering change controls)
- Interface with other departments regarding documentation requirements
- Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes
- Provide back up and support to the Quality Assurance Manager
- Initiate, carry out and maintain change control documents
- Other duties assigned as needed
- Ability to develop and manage client relationships
- Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
- Exceptional communication and organizational skills
- Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
- Willingness to travel to various clients site throughout the greater Raleigh-Durham area, in addition to potential for out-of-state projects
- An Associate's level or higher degree in a science-related field such as Biology, Chemistry, Engineering, etc.
- 3+ years of applicable work experience in document control, technical writing
- 3+ years of GxP experience
- Knowledge of SOPs, work instructions, and regulatory requirements
- Understanding of Quality Management Systems (QMS)
We value our employees, and beyond the great pay and benefits we offer, we care most about offering opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to provide Equal Employment Opportunities, EOE/M/F/D/V, to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.