Job description

Join the team at Charter Medical and use your skills and experience to contribute towards improving the lives of patients globally!

Who We Are: Charter Medical, LLC is a life sciences company located in Winston-Salem, NC, that has supported the development of advanced immunotherapies for over 30 years. The integration of our single-use solutions in FDA-approved immunotherapies has helped improve the lives of patients globally. Our passionate team is committed to designing and developing quality products that support rapid growth in cell and gene therapy, bioprocessing, and blood management.

What We're Looking For: The Document Control Coordinator ensures the effectiveness of the document management system and training program, in support of FDA 21 CFR Parts 210, 211, 820 and ISO 13485:2016. The Coordinator works with the Management Team to assure compliance to customer requirements, external standards, and internal specifications/procedures.

What You'll Do:

• Implements and maintains the Quality Management System (QMS) documentation system and associated processes while ensuring compliance to applicable standards, regulatory and customer requirements and overall protection of company intellectual property.
• Assures the Document Change Control Request process is performing as stated in the applicable Work Instruction (WI).
• Routes, maintains and revises controlled documents and specifications including Standard Operating Procedures (SOPs), Work Instructions (WIs), and Internal Specifications following established processes to ensure revision control records are maintained.
• Assures control of quality records (including records retention) are compliant to procedure and WIs.
• Administers ZenQMS training program, granting employees access and assuring all training records are current to employees’ curriculum.
• Conducts new hire Quality Orientation Training.
• Work with Quality Management to assure that documents are released and become effective after personnel have been trained.
• Responsible for creation and revision of labels in BarTender as the Administrator/Super User.
• Assists in internal/external audits and supplying documents as applicable.
• Supplies applicable Metric Data as requested.
• Maintains the Deviation Log and issues deviation numbers.
• Maintains off-site storage of records, including requesting pickups, ordering boxes, etc.
• Performs other activities and other projects as requested by RA/QA Management.
• Acts as a Quality ambassador for the company to promote Quality culture.

Other Duties

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Ability to stand often
• Ability to sit frequently
• Ability walk and/or move around in a controlled environment often
• Ability to use hands to grasp and perform fine manipulation often
• Ability to stretch/reach with hands and arms often
• Ability to lift arms overheard rarely
• Ability to climb or balance rarely
• Ability to stoop, kneel, crouch, or crawl occasionally
• Ability to talk or hear often
• Ability to lift up to 50lbs rarely
• Ability to push and/or pull rarely

Who You Are:

• High school graduate or equivalent required.
• Associates Degree preferred.
• 2 – 3 years of relevant experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 210, 211 and 820) in one of the following functions: Quality Control/Assurance or Product Development, preferred.
• 1-2 years’ experience developing or maintaining a controlled document system in a regulated industry required.
• Intermediate or advanced level of knowledge of ZenQMS, BarTender, MS Office Suite and Adobe projects (specifically Adobe Acrobat Pro).
• Possess excellent communication, organizational and computer skills.
• Must be able to work independently and set priorities in alignment with business needs.

Why Join Us:

We promote a collaborative, high energy and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.

This position includes a compensation package that includes a base salary plus a quarterly bonus based on company performance. We offer a comprehensive benefits package including medical insurance with Rx, vision insurance, dental insurance, life insurance, 401(k) and employer matched contributions, paid holidays and paid time off.

Charter Medical is a drug-free workplace. All offers of employment are contingent on passing a drug screen as well as a background investigation (including a criminal courts history, driving record report if applicable, and social security name and number verification). The company provides reasonable accommodations for disabilities.

Charter Medical participates in E-Verify as appropriate in accordance with company guidelines and federal or state law. This includes providing the Social Security Administration and, if necessary, the Department of Homeland Security, with information from each new employee’s Form I-9 to confirm work authorization.

Charter Medical is an Equal Opportunity Employer. We maintain a commitment to providing equal access to employment. We value diversity and encourage applications from all genders, members of minority groups, LGBTQ individuals, veterans, and disabled individuals.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Winston-Salem, NC 27103: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Document management: 2 years (Preferred)
• FDA regulations: 2 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.