Title: Associate Consultant / Senior Associate Consultant / Consultant, Quality Assurance
Position Reference: 2020006
Primary Location: Flexible, ideally Eastern US
Travel: Some travel is required
At Latham BioPharm Group, Inc., you will support multiple clients to assure their development phase programs meet or exceed industry cGMP requirements by assisting in the creation and implementing corporate Quality Manuals, Quality Policy’s, SOP’s and training programs. In addition, perform batch record; review, approval and disposition of lots and labels. Manage deviations and CAPA identification to closures. Furthermore, you will provide audit support by assisting in conducting vendor qualification through routine scheduled audits.
The ideal candidate must be able to work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities.
Provide consulting services for LBG client including, but not limited to:
- Evaluation and disposition of materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of the Company's compliance with all governing regulations.
- Coordinate and/or support the preparation of procedures, processes and quality improvements.
- Assists in the coordination of significant quality events including fact-finding, investigation support, coordination of clinical quarantine and recovery actions.
- Collaboration with clients and vendors to ensure robust processing and continuous improvement.
- Manages investigations, change requests and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
Support the growth of the company and sale of new engagements.
- Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred.
- Effectiveness and creativity in approaching and solving technical problems
- In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Computer skills; knowledge and competency in PowerPoint, Excel, Outlook and Word.
- Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Demonstrated teamwork skills and ability to work independently.
- Attention to detail, flexibility and an awareness of production and quality control problems.
Preferred Experience and Skills:
- 1-2 years post-degree experience in the Pharmaceutical or equivalent industry (GMP related field).
- Familiarity with batch disposition (release) activities; prior batch disposition experience is a plus.
- Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs) is a plus and a strongly preferred skill.
- Previous experience in quality control, quality assurance, auditing or regulatory affairs.
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
- Demonstrated analytical and problem-solving skills.
Latham BioPharm Group, Inc offers a competitive base salary, annual bonus, professional career development and growth opportunities, medical, life, short and long-term disability, and Safe Harbor 401K plan options with 3% automatic contribution and up to 5% corporate match.