Description
JOB SUMMARY
Support and uphold the quality management system to ensure the consistent manufacture and testing of cGMP compliant drug products. These duties include providing oversight and general support of the compliance processes at Grand River Aseptic Manufacturing including, but not limited to, conducting internal audits, hosting client audits, supporting external regulatory audits (e.g. FDA, EU), maintaining regulatory reporting (establishment registration, DMF amendments and reports), writing effective audit reports, following up on audit responses and commitments internal and external, investigating and reporting on customer complaints, conducting and reporting on supplier quality investigations, and oversight and enforcement of the DEA registration.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Administer systems such as, customer complaints, internal audits, external audits and supplier quality investigations.
- Timely investigate and respond to clients regarding customer complaints according to requirements set forth in applicable quality agreements.
- Actively host client and prospective client audits, which may include coordinating requests, preparing subject matter experts for interviews, delivering GRAM welcome presentation, discerning and communicating the focus of the auditors, capturing dialogue/notes during audit, preparing and following up on audit responses to clients.
- Actively support regulatory inspections as preparation coordinator. Respond to, coordinate and fill requests, organize SMEs in support of regulatory inspections.
- Maintain drug master file by coordinating submission of annual reports and amendments as required.
- Actively conduct audits of third party providers (GMP suppliers, contract laboratories, service providers) including paper audits and on-site audits. Travel is < 20% of the time.
- Initiate quality agreements with providers as well as new clients, collaborating with external parties on content.
- Assist with preparation, review and drafting of annual product reviews.
- Coordinate regulatory reporting, including annual drug establishment registration, GDUFA registration, and annual DEA and Michigan controlled substance registration.
- Coordinate routine DEA inventory assessments.
- Report annual controlled substance inventory to the state of Michigan.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
- Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting 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.
Requirements
DESIRED SKILLS & ABILITIES
- Must have proficient computer skills in Microsoft Word, PowerPoint, Excel and Outlook, and be proficient in technical writing.
- Excellent written and verbal skills; Ability to communicate effectively with management, staff, and regulatory agencies by exhibiting excellent interpersonal skills.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented with sense of urgency.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Ability to work with a diverse customer base and interact with clients and regulatory authorities.
- Ability to work well independently, with minimal supervision, and in a cross-functional team environment.
- Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
The ideal qualified candidate is a QA/QC professional with a minimum of 5 years' experience within a pharma, biopharma and/or biotech manufacturing environment (aseptic filling environment a plus). Must have strong interpersonal skills and be a team player. The person also must be able to communicate professionally with clients and regulatory agencies. Certified Quality Auditor (CQA) certification preferred, or the ability to study, test and receive certification quickly. Ability to work in fast paced environment, with multiple external clients. Completion of an Bachelor's Degree in Life Sciences or applicable relevant experience.
GRAM supports Equal Opportunity Employment
