Quality Assurance Inspector

Sebela Pharmaceuticals • Holbrook, MA

23h • $24 - $30 • Onsite

About The Position

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women’s Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products . We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland. The Quality Assurance Inspector will be responsible for monitoring manufacturing operations for compliance to Standard Operating Procedures (SOP’s) and cGMPs. This position will be primarily in a manufacturing environment also with some desk time. Perform daily audits within the facility for compliance.

Requirements

• 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 GMP’s and FDA Guidance Documents.
• The requirements listed below are representative of the knowledge, skills and/or abilities required.
• Working knowledge of GMP’s and FDA Guidance Documents is essential to this function as well as proven ability to be detail oriented.
• 1+ years of manufacturing or pharmaceutical experience preferred
• High School diploma/GED required
• Detail oriented and strong organizational skills
• Writing and basic computer skills (Microsoft Word and Excel)
• Ability to interact with many departments

Responsibilities

• Verify that all manufacturing areas in operation follow current Good Manufacturing Practices (GMP’s) and specific standard operating procedures (SOP).
• Perform internal daily and routine audits of all systems within the operation.
• Document the results of audits performed and inform management of noncompliant issues.
• Issue labeling materials to manufacturing and ensure correctness and completeness of work performed.
• Review all Batch Record documentation and protocol procedures documentation to ensure they are being followed accurately by employees.
• Provide support to other departments as needed.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED