Description
Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan differentiates itself from our competitors by living our values of Integrity, Quality and Service.
Quality Assurance Associates will participate in the generation, review, approval and training in support of cGMP quality systems and will be responsible for Quality Assurance activities in one or more suites for manufacturing operations.
As a member of the quality assurance team, QA Associates are responsible to:- Develop, review, approve and/or maintain documents that support both Quality Assurance and Operations. This may include Batch Records, Protocols and Reports (Engineering, Validation, Qualification, Stability, etc.), Risk Assessments, Process Flow Diagrams, Standard Operating Procedures (SOP's), Investigations, and any other technical documents as required.
- Lead/represent QA on project teams in support of new product and manufacturing activities.
- Review and approve incoming materials including but not limited to active pharmaceutical materials, excipients, components, and packaging materials.
- Perform Quality oversight during manufacturing operations, including identifying and implementing process improvements through change control, investigations of non-conforming material, equipment, processes, etc., and review of the manufacturing documentation (batch records, logbooks, analytical testing data, protocol(s), etc.)
- Perform review and approval of executed documents.
- Assist in the identification, action, and resolution of changes and issues during manufacturing activities.
- Develop and implement SOPs specifically related to CGMP quality systems, operations, and the facility, including training and training file maintenance.
- Assist in management of quality systems on a company-wide basis, including document control, vendor quality, training, CAPA, change management, auditing, validation/qualification programs, and non-conformance investigations.
Behavioral Expectations include:- Strong work ethic and ability to accomplish tasks without supervision
- Exhibits leadership, both by work and example,
- Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment,
- Excellent interpersonal skills with the ability to communicate effectively,
- Basic computer skills (proficient in Microsoft Office applications),
- Excellent communication skills, both written and verbal,
- Possess honesty and integrity with a commitment to the highest legal and ethical standards,
- Treats every person with courtesy and respect,
- Knowledge of CGMP and regulatory principles,
- Commitment to quality in the manufacturing process,
- Ability to independently analyze and resolve complex issues,
- Strong sense of initiative, accountability, and responsibility
- Ability to independently analyze and resolve complex issues
The following qualifications are the minimum required for this role:- 5+ years of experience in the pharmaceutical/biotech industry. (Strongly preferred, not required)
- Demonstrated knowledge and understanding of CGMP and CGMP Quality Systems
- 4-year degree in a scientific discipline.
