Description
JOB SUMMARY
The Compliance Specialist-Complaints primary responsibility is to support and uphold the quality management system to ensure the consistent manufacture and testing of cGMP compliant drug products, especially with respect to investigating customer complaints. Additionally, 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), writing effective audit reports, following up on audit responses and commitments internal and external.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Timely investigate and respond to clients regarding customer complaints according to requirements set forth in applicable quality agreements.
- Support 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.
- Support audits of third-party providers (GMP suppliers, contract laboratories, service providers) including paper audits and on-site audits.
- 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.
- Support administration of the change control process by collaborating and performing assessments from time to time.
- 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 be computer literate and proficient in technical writing.
- 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 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 in a cross functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- Ability to work independently with minimal supervision, in addition to group/team setting.
- Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Ability to communicate effectively with management and staff.
- Excellent written and verbal skills.
- Ability to work in fast paced environment, with multiple external clients.
Qualified candidate is a QA/QC professional with a minimum of 2 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. This level of knowledge is normally acquired through completion of an Bachelor's Degree in Life Sciences or applicable relevant experience.
GRAM supports Equal Opportunity Employment
