Documentation Control Supervisor
Documentation Control Supervisor
Growing Pharmaceutical company is investing heavily in our Quality Department and expanding our team. We are adding a Supervisor to expand the depth of our Documentation Control department and mentor our team!
- Assist Quality Director with internal procedures/policies, state, and federal regulations at our Manufacturing Facility.
- Supervises and oversees Document Control personnel and workload.
- Provides guidance and training for Document Control Associates.
- Participate and assist with Document Control processes in conjunctions with initiatives, campaigns, and special projects.
- Assists with additional work duties or responsibilities as evident or required.
- Required to perform special tasks as directed by Director and Executive Management.
- Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.
- Utilization of Laboratory Information Management Systems (LIMS), SharePoint, Document Management System, and other software systems.
- Supervise the storage, archival and retrieval including but not limited to: controlled document versions, master batch records, logbooks and laboratory notebooks, and studies according to policies and procedures.
- Assists with tracking and managing controlled documents as needed.
- Supports other departments to ensure their controlled documents follow the change control cycle in a timely manner.
- Ensures Document Control functions are appropriately managed.
- Reviews daily production schedule to assess need for batch record generation as well as issuing assignments to Document Control personnel.
- Elevate to leadership issues of concern and improvement opportunities identified.
- Develop and perform training for Document Control personnel.
- Devise and administer performance evaluations for Document Control personnel.
- Hours of work: Monday thru Friday on an 8-hour day shift
Expertise: Knowledge & Skills:
• Knowledge of good analytical and laboratory techniques, pharmacy preparations, cGMP’s, GLP’s, SOP’s, USP and FDA requirements
• Knowledge in statistical data analysis and its application to pharmaceutical quality controls
• Good analytical, writing, interpersonal, and organizational skills
• Ability to meet deadlines
• Must be able to work independently
• Strong communication skills
• Ability to demonstrate leadership skills
• Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
• Software packages supporting statistical data analysis, word processing, and project management
Qualifications - Experience/Training/Education/Etc: Required:
• B.S. degree in Microbiology, Chemistry, or related industry
• 3 – 5 years’ experience in Pharmaceutical / medical device industry
• Supervisory/Leadership experience is desired but not required
This position will fill as soon as a qualified candidate is identified. Please apply today for immediate consideration to [email protected]
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.