Document Control Specialist
Bright Path Labs Kannapolis, NC Full-Time
Apply on company site
Job Details
favorite_border
Document Control Specialist
at Bright Path Laboratories, Inc
The Company
Bright Path Laboratories, Inc. (BPL) is a leading U.S.-based advanced drug development and manufacturing company that has answered the call to recast Americas reliance on foreign pharmaceutical ingredients and medicines using patented AI-enabled continuous flow technology.
Founded in 2017, BPLs game-changing platform drives rapid synthetic route development and highly automated, controlled, and inexpensive deployment of scaled cGMP commercial manufacturing enabling the manufacture of Active Pharmaceutical Ingredients (APIs) and specialized medicines (e.g., orphan drugs to treat patients with rare diseases) here in the United States. It is estimated that the U.S. imports 80% of the APIs it uses for medicines and BPL is uniquely positioned to reduce our dependency on foreign suppliers and securitize Americas pharmaceutical supply chain.
The Opportunity
We are searching for a highly motivated Document Control Specialist to lead our cGMP Document Control and Training Management systems for the company. This newly created role will report into our Head of Quality and be based at our site in Kannapolis, NC.
Specific responsibilities will include, and are not limited to:
• Execute and maintain our Document Control system, including writing document change control processes, issuing and reconciling quality management system documents, writing and formatting documents, maintaining GMP records in the electronic document management and quality management system (TrackWise), archiving documents per applicable procedures and providing end user customer support for the QMS system.
• Maintain manual logbooks for quality management systems and issue document numbers as required.
• Provide oversight of the Training Management System and assist in the development of training plan curriculums and GMP training materials.
• Ensure that BPL personnel are properly trained in document control and ensure compliance with cGMP regulations.
• Write and revise document control and other quality procedures including leading the development and roll-out of future training management tools.
• Follow policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents including document change requests.
• Support internal and external audits and regulatory inspections, including data gathering, interviewing, or escorting auditors during the audit, assisting with document retrieval /organization support during regulatory inspections.
• Perform Document Control metrics reporting and analysis for the local site. This may require the use of relational databases and reporting tools to collate and analyze quality data.
• Collaborate with cross-functional departments to ensure timely implementation of document change requests and other quality system documentation such as change controls, deviations, CAPAs, etc.
• Adhere to all cGMP compliance and regulatory mandates, and quality requirements.
• Perform other related duties as assigned to meet departmental and BPL objectives.
Preferred qualifications
• Bachelors degree in technical or business discipline; or the equivalent combination of education and progressive experience with increasing levels of responsibility in a cGMP environment.
• Minimum of 5 years of relevant document control management experience in a cGMP/FDA regulated environment.
• Thorough understanding of cGMP document control regulations and requirements, and ability to translate to operational details and communicate those to BPL staff.
• Strong computer skills with MS Office (e.g., Word, Adobe, and Excel) and with Quality Systems (e.g., Document Management System, Quality Management System).
• Experience with Electronic Document Management Systems such as Trackwise or similar system.
• Excellent oral and written communication skills.
• Highly organized with a strong attention to detail.
• Excellent communication and customer service skills.
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Compensation & benefits
• Great colleagues
• Competitive salaries
• Stock compensation plan you will be a Bright Path Labs co-owner
• Health, dental, and vision benefits
Bright Path Labs is not currently offering visa sponsorships for any position. Please only apply if eligible to work in the U.S.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, or veteran status.
Recommended Skills
• Adobe
• Attention To Detail
• Change Control
• Communication
• Coordinating
• Customer Service
Apply to this job.
Think you're the perfect candidate?
Apply on company site
Help us improve CareerBuilder by providing feedback about this job: Report this job
Job ID: f2ee9i7
CareerBuilder TIP
For your privacy and protection , when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.