Description
Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!
Overview of this Position:
The Senior Compliance Specialist supports the development, implementation, and maintenance of relevant quality system initiatives in support of their function. This role coordinates and executes activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements. This position assumes process ownership of the supplier quality management system. Additionally, as a process owner, the ideal candidate is adept at troubleshooting problems, is responsible for identification of trends, ongoing monitoring of the system, and providing and implementing recommendations for continuous improvement. This is an on-site role with approximately 40% traveling for external auditing activities.
Non-Negotiable Requirements:
- Bachelor’s degree in Life Sciences with 5-10 years relevant experience.
- QA/QC professional with a minimum of 10 years of experience of within a pharmaceutical, biopharma and/or biotech. manufacturing environment.
- Knowledge of current Food and Drug Administration (FDA) laws, regulations, practices, and guidelines.
- Experience implementing, administrating, and maintaining electronic quality systems.
- Must have proficient computer skills in Microsoft Word, POwerPoint, Excel, and Outlook.
- Must be highly skilled in technical writing.
Preferred Requirements
- Prior experience working in a fast-paced, emerging growth CMO is preferred.
- Prior project management experience is preferred.
- Prior experience with aseptic processes and equipment is preferred.
Responsibilities Include (but are not limited to):
- Maintain up-to-date knowledge of industry and regulatory trends to ensure assigned processes remain compliant with stated expectations and best practices. Processes may include, but are not limited to, supplier quality management, internal audits, customer complaints.
- Actively conduct audits of third-party providers (GMP suppliers, contract laboratories, service providers) including paper audits and on-site audits.
- Initiate and maintain quality agreements with providers, collaborating with external and internal parties on content.
- Ensure process aligns with all applicable internal requirements, client requirements, regulations, and industry best practices.
- Monitor process performance metrics, including identification of trends that require corrective or preventive action, cross-functional collaboration to determine the root cause of process performance issues, and taking the necessary action to improve performance.
- Actively contribute to new process quality improvement projects.
- Support administration of the change control process by collaborating and performing assessments from time to time.
- Troubleshoot and support the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Work effectively with cross-functional teams, including with senior level and middle management, project management, QC Laboratories, Facilities/Engineering and Operations.
- Provide routine communication to peers and cross-functional management on status of records, execution plan barriers, and potential product quality impact concerns.
- Support quality systems that may include Regulatory Surveillance, Annual Product Reviews, Controlled Substance Program, customer complaints, internal audits, and external audits.
Full job description available during interview process.
What Sets GRAM Apart from Other Employers:
MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
PAY: Depends on Experience and is discussed during the interview process.
If you meet the required criteria listed above, GRAM welcomes you to apply today!
Skills Required
- Bachelor's degree in Life Sciences
- 5-10 years relevant experience
- Minimum of 10 years in QA/QC within pharmaceutical, biopharma, or biotech
- Knowledge of FDA laws and regulations
- Experience with electronic quality systems
- Proficient computer skills in Microsoft Office
- Highly skilled in technical writing
What We Do
Grand River Aseptic Manufacturing (GRAM) is a leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for biologics, small molecules, and vaccines, offering capabilities for liquid and lyophilized vials, syringes, and cartridges.
