The Manufacturing Quality Assurance Specialist is responsible for manufacturing operations support. This position will work directly with manufacturing, analytical, and other departments to ensure that products conform to quality standards and all applicable regulatory requirements.
- Provide Quality support for manufacturing operations.
- Responsible for batch record issuance and review.
- Coordinate and facilitate Deviations, Change Controls, CAPAs and OOS events as related to manufacturing operations.
- Review and approve validation protocols for manufacturing related equipment, facilities, and utilities.
- Review and approve calibration and maintenance events.
- Support the Quality team to achieve quality goals and metrics.
- Communicate effectively with internal personnel, as well as external customers.
- BS or BA Degree with 2-5+ years, MS Degree with 2+ years, working in a Biotech or Pharmaceutical FDA regulated industry.
- Prior experience in a manufacturing quality assurance support role, preferably in oral solid dosage and drug substance manufacturing.
- Prior experience maintaining pharmaceutical quality systems.
- Experience, or understanding, with international guidance and their application to early to late stage pharmaceutical programs.
- Experience with and working knowledge of cGMP and GLP quality systems, policies, and regulations/guidelines.
- Ability to influence others for the better of the company.
- Participate in developing department goals, objectives, and systems.
- Exceptional analytical and problem-solving skills with the proven ability to think strategically.
- Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
- Ability to influence employees in a matrix organization to ensure completion to pre-established due dates.
Our client is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.