PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.SUMMARY:The Document Control Specialist is responsible for managing controlled documents in compliance with regulatory requirements. The Specialist supports audits, runs training reports, and assists with GMP Training and routing changes for contract manufacturing organizations. Strong communication, organizational, and technical skills are essential for success in this role, which requires a detail-oriented approach and the ability to work both independently and in a team environment.Work Schedule: Monday - Friday 8:30am-5pmJOB QUALIFICATIONS:
- Bachelor's degree required in relevant field.
- 3-5 years of experience in document control or related position.
- Competence in FDA, cGMPs and Guidance Documents ICH Q8(R2), Q9 and Q10 preferred.
- Proficiency in Microsoft Office including Windows, Excel, Word, Visio and PowerPoint.
- Working Knowledge of Oracle and Agile a plus.
- Excellent verbal and written communication skills.
- Must be flexible, self-motivated and detail oriented.
- Ability to work independently, prioritize, resolve problems and multi-task.
- Must be able to work in a team environment, demonstrating ability to take direction, participate, take lead and work with personnel at all levels of the organization.
POSITION RESPONSIBILITIES:
- Partner with Subject Matter Experts (SME) on review of controlled documents on a regular basis.
- Track and trend Quality Policies, SOPs and WI's pending review.
- Review, track and close CRN's in Agile associated with controlled documents including but not limited to SOPs, WIs, Forms, Documents, Protocols, and Batch Records.
- Review, verify, and update content of controlled documents when CRN is initiated.
- Support customer, third party, and regulatory audits from document control perspective.
- Run reports for specific controlled document training in Oracle Learning Management.
- Assist with GMP Training as needed.
- Route Changes for contract manufacturing organizations (CMO).
- Backup change analyst for other workflows as needed (Parts, support other sites).
- Any other Quality projects or support requested by Quality Systems Manager.
PHYSICAL REQUIREMENTS:
- This position is primarily sedentary, working at a desk or in attending meetings.
- Work safely and adhere to all OSHA regulations as well as company safety policies and procedures.
- Work in a manufacturing environment, when necessary.
BENEFITS:PLD is a proud equal opportunity employer offering many corporate benefits, including:•Medical and Dental Benefits.•401K.•Group Life Insurance.•Flex Spending Accounts.•Paid Time Off and Paid Holidays.•Tuition Assistance.•Corporate Discount Program.•Opportunities to Flourish Within the Company.Starting Salary: $60,000#HP1