What are the responsibilities and job description for the QA Document Control Supervisor position at American Regent, Inc.?
Nature and Scope
This position is the day-to-day lead of the Document Control (DC) Group. The DC Group is responsible for controlled documents associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The DC Group provides support to other departments as needed and is critical in maintaining production schedules and meeting Company Goals. The DC Group participates in the administrative functions of the Change Control Process. This includes all aspects of the document lifecycle such as: editing, reviewing for conformance to formatting standards, tracking, and issuing as per applicable SOPs. The DC Supervisor supervises the day-to-day activities of the DC Group and ensures appropriate management of the DC System (Veeva EDMS). The DC Supervisor works under the direct supervision of in the Document Control and Change Control Manager in Quality Assurance.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Supervision of the revision and maintenance of controlled documents including Standard Operating Procedures, specifications, protocols, and other miscellaneous controlled documents in Veeva.
- Supervision of the issuance of batch records for manufacturing/production.
- Supervision of the Central Archive and responsible for providing guidance for document filing and destruction within the Central Archive.
- Facilitation of personnel accountability for both the document and the document control process including: reviewing for conformance to formatting standards, editing, proofreading, and tracking of proposed changes. Auditing of documents, DCRs, DCCs in Veeva EDMS.
- Responsible for document metrics which are reported to Senior Management.
- Provide support for the Regulatory Affairs Group, regulatory inspections, and internal/external audits.
- Ensure all work output of the Document Control Group is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
- Responsible for updating SOPs related to the document control process.
- Provide effective leadership for 4 employees including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
- Perform any other tasks/duties as assigned by management
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Associate’s or Bachelor’s degree in Life Sciences or related field is preferred or equivalent work experience in the management of controlled documentation.
- 3-5 years experience in the Document Control or Document Management function required.
- 2 years experience in a supervisory role preferred.
- Experience in an FDA-regulated environment is required.
- Experience with electronic document management systems is preferred.
- Intermediate skills in Microsoft Office, Word, and Excel are required; Visio and Access are preferred.
- Excellent organizational, interpersonal, and communication skills (written and oral) required.
- Ability to take feedback constructively and function in a team oriented work environment
Physical Environment and Requirements
- Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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