Bryllan LLC · 2 months ago
Pharmaceutical Quality Assurance Associate
Brighton, MI
Full-time
Onsite
Mid Level
3+ years expBryllan LLC is a company focused on Quality Assurance in the pharmaceutical sector, and they are seeking a Quality Assurance Associate. The role involves overseeing quality systems management, document generation, and providing quality oversight during manufacturing operations.
Machinery ManufacturingManufacturingPharmaceuticalService Industry
Responsibilities
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
Other duties as defined by Biovire
Qualification
Required
BS in scientific discipline
Demonstrated knowledge and understanding of CGMP and CGMP Quality Systems
Strong work ethic and ability to accomplish tasks without supervision
Demonstrate leadership both by words and leading by example to foster Biovire One Team culture
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
Preferred
3+ years experience in the biotech/pharmaceutical industry preferred
Company
Bryllan LLC
11-50 employees
H1B Sponsorship
Bryllan LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Early StageRecent News
Crain's Detroit
2022-01-06
Company data provided by crunchbase