Provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight Finishing Operations (Inspection, Labeling, Packaging. This position works closely with all levels of the Operations, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.
ESSENTIAL DUTIES & RESPONSIBILITIES
Provide supervision to Quality Specialists and Quality Technicians of various levels. Responsibilities include managing, motivating, coaching and mentoring.
Ensure Quality support and oversight of Finishing operations across all shifts, including occasional weekend support.
Oversight and management of the batch record review and final release processes.
Client support / interaction related to these processes.
Interface with auditors, including client representatives and regulatory agencies.
Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including: Procedures
Test Methods, Master Batch Records, Risk Assessment Reports
Support Agency, customer and vendor audits as needed.
Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.
Ability to interpret and relate Quality standards for implementation and review.
Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
Ability to portray an appropriate level of integrity and professionalism at all times.
Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
Ability to complete tasks accurately and according to established timelines.
Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
Proficiency in both written and verbal communication and presentations.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base (internally and externally).
Ability to work well in a cross-functional team environment.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Qualified candidates have at least 3 years prior experience in a QA Specialist role; prior leadership experience preferred. Prior experience interacting with regulatory authorities is preferred. The level of knowledge required to successfully perform these duties is normally acquired through completion of a Bachelor's Degree in Life Sciences or a related field and/or a minimum of 4+ years related work experience.
GRAM supports Equal Opportunity Employment