GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!
Title: Quality Assurance Manager
Job ID: 7068
Location: West Greenwich, RI
Duration: 9-Month Contract (w/ possible extension)
Pay Rate Range: Depends on Experience (hourly, w2)
- M-F; Needs to be flexible on shifts as needed
- Responsible for hiring, training, supervising and performance management of staff.
- May perform or oversee the following functions:
- Review and approve product MPs
- Approve process validation protocols and reports for Mfg. processes.
- Approve Environmental Characterization reports
- Approve planned incidents
- Represent QA on NPI team
- Lead investigations
- Lead plant audits, participate in site audits
- Approve change-over completion
- May perform work of QA Specialist
- Own & report company document tracker
- Facilitate meetings
- Provide updates to management
- Ensure the alignment between the document tracker vs capital project schedule
- Quality oversight of startup activities for facilities, utilities, equipment, systems and process with alignment and integration into the Company Quality Systems, including:
- Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports.
- Oversee execution of and change management related to the following: factory acceptance, commissioning tests, facility qualifications and validation activities.
- Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
- Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
- Oversee and provide guidance during on-the-floor analytical testing.
- Audit and inspection support
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
- Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
- Assess changes that could potentially impact product quality.
- Provide management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.
- Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks.
- Perform training activities, as needed.
- Project management skills
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Collaborate and communicate with higher level outside resources.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Strong communication (both written and oral), facilitation, and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Ability to lead and influence staff outside own organization.
- Ability to motivate staff and manage and distribute work loads.
- Able to manage performance issues and conflict
- Ability to provide direction and establish goals for individual staff members and work group.
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interact with regulatory agencies
- Demonstrate the Company Values/Leadership Practices
Top Must Have Skills:
- Commissioning and Qualification
- Technical Writing
- Quality oversight
Educational and Experience Requirements:
- Ideal candidate- 5+ years industry experience.
- Commissioning and Qualification experience. experience with CAPA, validation, Technical Writing. Quality oversight.
- Doctorate degree or
- Master's degree and 3 years of directly related experience or
- Bachelor's degree and 5 years of directly related experience.
- Previous managerial experience directly managing people and/or experience leading
- teams, projects, programs or directing the allocation of resources.
Note to Applicants:
We will not respond to everyone personally - qualified candidates will be contacted for a screening.
Please submit your resume in a Word document.