QA Document Control Manager
This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
This position will report to the Sr Director of Quality. The Quality Assurance Document Control Manager is responsible for overseeing the document control activities within the Quality Assurance Department. This role ensures the accurate and efficient management of all controlled documents, Standard Operating Procedures (SOPs), batch records, and quality system documents. The manager will lead a team of document control specialists and technicians and collaborate with cross-functional teams to maintain compliance with regulatory requirements and company policies. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, attention to detail, and excellent communication with other functional areas and sites.
Why Join Leiters Health?
Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!
At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.
- Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
- Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
- Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
- Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
- Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.
Who We're Looking For:
We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!
Essential Functions:
- Document management:
- Supervise the document control process, including the creation, review, approval, distribution, and archiving of controlled documents
- Ensure all documents are maintained in accordance with company policies, regulatory requirements, and industry best practices
- Manage the document control system to ensure the integrity and accessibility of documents
- Develop the companies electronic document management system and drive acceptance / improve user experience across the company.
- Lead and mentor the document control team, providing guidance and support to ensure efficient workflow and high-quality output
- Provide training to staff on document control processes and systems
- Support cross-functional teams in understanding and adhering to document control requirements
- Ensure compliance with FDA, GMP, state, and other regulatory requirements related to document control
- Participate in internal and external audits, providing documentation and support as needed
- Implement corrective actions related to document control findings from audits
- Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends
- Identify opportunities in the department for process improvements and implement changes to enhance efficiency and effectiveness
- Create, revise, and approve documents, including, but not limited to, SOPs, batch records, deviations, CAPA, and change control.
- Oversee the final batch release process driving efficiency and reducing turn-around times.
- Other duties as assigned.
Supervisory Responsibilities:
- Lead and manage a team of Quality Specialist and
- /or Technicians, providing direction, support and development opportunities.
- Conduct regular performance reviews, provide constructive feedback, and implement performance improvement plans as needed.
- Provide a positive and collaborative work environment, addressing and resolving conflict promptly and fairly.
Experience and Necessary Skills:
- Knowledge and experience with the US FDA cGMPs, preferably in a commercial compounding outsourcing facility
- Knowledge of compounding techniques and controlled environments
- Knowledge of appropriate materials and conditions
- Knowledge of and experience with electronic document management systems (Dot Compliance experience is preferred).
- Able to identify potential adverse issues
- Excellent organization and documentation skills
- Detail oriented
- Computer skills, including Microsoft Word and Excel
- BS or BA degree (in a scientific discipline desired) required
- Minimum of 5 years of experiencing working in an FDA-regulated environment
- Able to lift up to 20 lbs and stand for up to two hours when required
Benefits:
- 100% employer paid medical plan.
- Dental & Vision insurance options including FSA & HSA
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
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 or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
