Mineralife Nutraceuticals is looking for an experienced Quality Control Manager that is responsible for overseeing and coordinating the quality assurance (QA) program at Mineralife.
You will develop, interpret, and implement quality policies, manages quality systems, and facilitates regulatory compliance inspections.
The primary responsibilities include:
- manages QA operations to support the GMP manufacturing,
- testing and release of finished product under FDA standards and internal procedures,
- is responsible for conducting investigations into GMP-related issues, management of the QA change control process,
- SOP preparation/revisions,
- and GMP training programs.
You will be instrumental in assisting in the formulations of product development and interfacing with various formulators and contractors.
Candidates that have a working history in an FDA Regulated environment with industry experience within Food, Dietary Supplements or Pharmaceutical Manufacturing will be immediately considered.
Position Responsibilities and Duties:
- Oversee the internal and external audit programs, which focus on cGMP compliance, regulatory agency inspection readiness, and for-cause inspections.
- Recommend systems for audit; write audit plans, coordinate scheduling, conduct and write reports to close audits. Follow-up on necessary corrective actions.
- Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.
- Manage documentation, reporting, and closure of compliance issues, and conducts trend analysis of audit results and provide Executive management with initial root cause analysis.
- Review GMP quality metrics. Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments.
- Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
- Oversee investigations of nonconforming products, customer complaint, laboratory out of specifications, and related problems. Ensures all investigations are performed and closed in a timely fashion. Monitors and reports on adverse events.
- Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies to management and staff. Participate in or lead teams for special projects as assigned.
- Develop and work with staff to implement quality process controls relating to all areas of Mineralife operations, including quality maintenance, facilities and equipment, materials management, production, release, packaging, and labeling.
- Prepare and present Quality Management Reports for management.
- Direct the Annual Product Review process.
- Advises executive management on external environment and strategic compliance trends impacting our business.
- Manage company-wide training initiatives and document control systems.
- Preferred backgrounds with work history in an FDA Regulated environment with industry experience within Food, Mineral Supplements or Pharmaceutical Manufacturing.
- Bachelor's degree and a minimum of 5 years of quality assurance experience.
- Extensive working knowledge of GMP regulations and experience with compliance inspections.
- Strong knowledge and experience with 21CFR111, and 21CFR117.
- Ability to effectively lead teams and manage staff.
- Strong project management and organizational skills.
- Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to detail and presentation skills).
- Ability to read, analyze, and interpret complex documents, comprehend and communicate instructions and written procedures, ability to respond effectively to sensitive inquiries or complaints.
- Ability to review and revise documents with proficient grammar and spelling skills, and to write routine reports and correspondence, and speak effectively before groups.
- Mathematical: can apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations, and apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems, and deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases, and can deal with a variety of abstract and concrete variables.
- Monday-Thursday 8am-5pm, Friday 8am-1pm
- This position is located at our Colorado Springs manufacturing headquarters.
- Business casual office attire.
- Health, Dental and Vision Insurance
- Life and disability Insurance
- Retirement Matching
- Bonus incentive program