Quality Inspector at Sebela Pharmaceuticals Inc. in Holbrook, Massachusetts

Job Description:

Sebela 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 285 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 Inspector will be responsible for monitoring manufacturing operations for compliance to Standard Operating Procedures (SOP's) and cGMPs. Perform daily audits within the facility for compliance. Assist with verification of critical manufacturing and packaging processes. PRINCIPAL DUTIES AND RESPONSIBILITIES

• Review all Batch Record documentation and protocol procedures documentation to ensure they are being followed accurately by employees.
• Issue labeling materials to manufacturing and ensure correctness and completeness of work performed.
• Verify that all manufacturing areas in operation are following 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.
• Working knowledge of GMP's and FDA Guidance Documents is essential to this function as well as proven ability to be detail oriented.
• Provide support to other departments as needed.
• Other duties as assigned.

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 GMP's and FDA Guidance Documents. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• High School diploma/GED required
• 1+ years of manufacturing or pharmaceutical experience preferred
• Good knowledge of FDA cGMP's
• Detail oriented and strong organizational skills
• Writing and basic computer skills (Microsoft Word and Excel)
• Ability to interact with many departments

PI259598408

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