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Form of workSebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women’s health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women’s Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth.
Our culture is characterized by a high degree of urgency, open dialogue, and collaborative discussion across all levels of the team, a willingness to challenge the “traditional” approach, and shared ownership of the organization we are building and of our results. We are all willing to step in and do whatever is needed on any given day, regardless of the title we hold. We strive to create a positive, collaborative, inclusive work environment in which all employees can learn, develop, and grow.
The QA Technician will receive, inspect, sample, and test raw materials and components; status tag raw materials and components, monitor stability chambers, pull stability samples as required and provide them to the lab, assist with inspection and tagging of finished product lots.
Duties and Responsibilities
- Assist and support the manufacturing process with verification of critical manufacturing and packaging processes.
- Trained in Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP) that pertain to Braintree Laboratories.
- Reviewing the receiving report generated by the warehouse
- Generates status tags (quarantine) for raw material or components accordingly.
- Generates status tags (approved) for Purchasing Specification components.
- Sampling of incoming items, raw material or components.
- Testing of incoming components to the current Braintree Laboratories C of A's.
- Applies status tags (approved) to all incoming materials and finished products.
- Changes the status of components and raw materials in the Microsoft Dynamics GP system.
- Follows the stability program and pulls samples from the stability chambers at the request of the Stability Coordinator.
- Performs daily checks on the stability chambers.
Qualifications:
To perform this job successfully an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in cGMPs. The requirements listed below are representative of the knowledge, skills and/or abilities required.
- High School diploma required
- 3+ years in a pharmaceutical environment preferred
- Knowledge of manufacturing operations using GMPs.
- Demonstrates accuracy and thoroughness with good attention to detail
- Excellent written/verbal communications skills
- Experience with Microsoft Office Suite including Outlook, Word and Excel
- Ability to collaborate effectively with cross functional departments
