The position supports the Quality function on the manufacturing floor under the direction of the Associate Director of Quality Operations and Lean Enterprise. The goal of the position is to drive a culture of Quality through adherence to GMP requirements. In addition, through the use of Lean principles reduce waste; optimize processes, improving operational/organizational efficiency and training. All of these will in turn improve product quality, consistency and defect prevention through the removal of organizational, cultural and technical obstacles.
The Compliance Specialist will engage in the 24/7 support of API manufacturing and collaborate with Production Supervisors and Process Engineers to ensure GMP compliance and demonstrate a progressive growth toward independently executing against objectives aligned to the executive business plan to accomplish the following responsibilities:
Communicate related performance of Quality and Lean Enterprise metrics through progress reports, quality totem poles and tail gate meetings for plant personnel to enhance awareness and promote compliance.
- Comply with all EH&S rules and performs alternative duties as assigned by Management.
- Conduct frequent audits of plant to ensure audit readiness, pre-campaign production startups and on the floor review of batch records, facility/equipment cleaning and use logs.
- Assist in the investigation of deviations in the plant for gathering information and interviewing staff for use in Quality Assurance investigations.
- Perform inspections of controlled rooms to ensure cleanliness and sanitization.
- Under the guidance of the Lean Steering committee, oversee and drive the execution of specific Lean Manufacturing projects, such as: 5S, Standard Work, Kaizen events, etc.
- Support implementation of various Quality initiatives related to CAPA’s, internal/customer and regulatory audits, trainings, etc.
- SKILLS AND KNOWLEDGE
- Ability to provide effective direction, leadership, assigns action items, conflict resolution and team building.
- Demonstrated abilities to plan and prioritize work load
- Interpersonal skills to work with all levels of the organization: management, support departments and operations staff.
- Presentation skills and ability to communicate effectively, both verbally and in writing with an understanding of the applicable audience.
- Knowledge of cGMPs (21 CFR 210/211, Q7A and ICH guidelines).
- Require the use of various computer systems and software to produce schedules, data and reports.
- Require the understanding of fundamental chemistry, chemical and analytical equipment for API manufacturing.
- Demonstrate a progressive learning of the systems and processes in the plant in order in order to promote awareness of GMP deficiencies.
- Utilize team based problem solving techniques, advocate and promote awareness of the group’s effort through personal interaction of various functional groups.
- SPECIAL WORK CONDITIONS
- Personnel will be required to work in extreme temperature differences and areas where direct chemical material exposure can take place.
- Must have a high consciousness for personal safety.
- May be required to utilize a variety of personal protective equipment (respirator, Tyvek, etc.).This position is for off shift coverage on a rotational or permanent basis.
- Bachelors in life sciences or equivalent years of experience in a GMP environment in a Quality or Supervisory role. Lean Manufacturing education/credentials are ideal but not required.
- This position requires off-shift coverage
Ampac Fine Chemicals is a leading manufacturer of active pharmaceutical ingredients and registered intermediates under cGMP guidelines for commercial customers in the pharmaceutical industry. Additional information about our Rancho Cordova facility can be obtained by visiting our website @ #removed#
Role: Compliance Specialist (QA)
Location: Rancho Cordova,
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