QA Specialist cGMP
The QA Specialist III ensures progress and guides completion of milestones associated with quality assurance responsibilities in support of: Global Product Quality Complaints (PQC) processing. Acts independently to receive, log and reconcile received product quality complaints. Performs data entry of complaint information into the cGMP electronic tracking system. Assists with periodic reconciliation of product complaint e-mail boxes and local tracking logs. Assists with the PQC investigations conducted by the global complaints handling unit as required. Assist with the tracking and compliant processing of returned investigational samples. Uses sound judgement to develop solutions to a variety of moderately complex quality events and issues. Conducts the QA duties in compliance to global SOPs, cGMP's and in accordance with company policies, procedures, and federal regulations.
1. Ensures Quality and Compliance for global product complaint program activities against internal policies and procedures as well as domestic and international GMP regulations.
- Partners with internal cross-functional areas, to execute a best in class GMP Global Complaints program by supporting the organization's operational excellence of ongoing compliance and continuous improvement activities.
3. Supports review of finished product contract packaging and shipping batch records and performs lot disposition to certify compliance with specifications and procedures and ensure that product is delivered on time of supply need.
4. Interacts with local and global Quality Assurance team members to ensure global complaints are processed, investigated and managed as per Global procedures
5. Evaluates Product Quality Complaints related to product quality issues or adverse event reporting, working effectively with internal/external partners as require to include; sample evaluation, thorough lot/product history trend analysis, and product impact assessment.
6. Assist with the management of CAPA related to Global product complaint investigations as required and in collaboration with local Quality staff.
- Minimum of 4-8 years cGMP related experience in biopharmaceutical / pharmaceutical or related industry with 3-5 years direct QA experience in a cGMP environment
- Knowledge of domestic and international regulatory requirements related to cGMP operations
- Experience with respect to product quality complaint management systems
- Experience with electronic Quality Management systems such as SAP, TrackWise, firstDocs, etc.
- BS/BA degree in Chemistry, Biology or related field required,
- Excellent written and verbal communication and negotiating skills.
- Strong interpersonal and teamwork skills
- Aability to make sound business decisions using facts and good judgment
- Ability to manage multiple priorities in an fast pace work environmentCompany Description Armstrong Consulting Group helps companies in diverse industries by providing contract, contract to hire and permanent staffing solutions in all areas of Information Technology, Engineering, Pharmaceutical and Administration.
We attract, recruit and deliver the highest quality professionals best suited for organizations by fully understanding the requirements and culture of our customers. As a highly respected and professionally managed team with over 25 years experience in the staffing industry, we foster long term relationships with clients and candidates as they successfully grow their businesses and careers.