This position serves as a dedicated resource for the administration of controlled documentation and documentation systems at the Akorn Somerset site. Associated documentation, systems and activities provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution. It also applies to controlled documentation associated with employee training, facility/utility/equipment descriptions, calibration and maintenance, as well as associated documentation processing mechanisms (e.g. change control, archiving, storage, etc.)
- Supervise daily activities of documentation specialists
- Issue Batch production records and ancillary documents to Manufacturing for batch execution..
- Process Document Change Requests including the following:
- Assign document numbers
- Edit, prepare, process and distribute controlled documents
- Retrieve obsolete SOPS
- Prepare and maintain SOP index
- Edit and maintain a Tracking Log for DCRs
- Assign Document Change Request (DCR) tracking numbers
- Ensure DCRâ€™s are circulated to appropriate reviewers for approval
- Prepare, schedule and conduct Change Requests Board meetings
- Provide training and assistance to Change Owners
- Facilitate/Coordinate/Provide GxP documents and document Change Control data for Change Controls, annual product reviews, regulatory submissions and annual reports.
- Facilitate and coordinate with other departments to provide Change Control status/updates in support of Regulatory Audits.
- Provide and report Change Control Metrics for Management Reviews (Weekly, Monthly and Quarterly)
- Responsible for communicating Site Change Controls affecting product release to Quality and Supply Chain Management.
- Maintain appropriate Tracking Logs and databases.
- Coach and train Staff on Veeva Quality docs implementation. (Electronic database system).
- Initiate CAPAâ€™s and investigations in Track-wise.
- Coordinate with the Training group for the evaluation of required training for all employees relating to the Document System.
- Coach and Develop Staff
- Facilitate and coordination of Batch Records updates/Process Improvements.
- Approving work orders in the BMRAM system.
- Facilitate and coordinate with other departments to support Regulatory Audits.
- SOP updates, reviews and approvals.
- Reviewing DCRâ€™s and CCRâ€™s for completeness and accuracy.
- Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
EDUCATION AND EXPERIENCE:
- Excellent interpersonal, oral, and written communication skills.
- Requires exceptional attention to detail with the ability to focus on current assignments.
- Must have accomplished skills in computer-assisted documentation systems.
- Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
- Must have a team work attitude.
- Will interact with all functional departments within the company including hourly, professional and management personnel.
- Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
- Bachelorâ€™s degree (BS) from four year college or university
- Minimum of two (2) yearsâ€™ experience in the pharmaceutical industry, in a documentation processing or related discipline.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements include:
Company Overview Who we are?
- Ability to hear accurately the spoken word with moderate office noise or plant noise
- Ability to apply deductive reasoning and understand complicated issues
- Ability to receive instructions and follow work rules and company policies
- Ability to follow safety and security practices
- Ability to meet deadlines and effectively deal with office stress
- Ability to accurately communicate ideas, facts and technical information
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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