Senior Quality Manager

Calling all Senior Quality manager is in Dallas/Irving TX Area.

  • Irving, TX
  • $110,000 - $140,000
  • Managed by Jobot Pro: Anna Ponas
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A bit about us:

Our client is a Nutrition manufacturing company in the Irving/Dallas, TX area. Their supplement products are designed to promote wellness, weight loss, health and muscle building.


Why join us?

Job Type: Full-time

Pay: $130,000.00 - $140,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee discount
Flexible schedule
Health insurance
Paid time off
Vision insurance
Schedule:

Monday to Friday
Supplemental pay types:

Bonus pay

Our client is a family style organization.

Job Details

Position Summary:

The Senior Quality Assurance Manager will be responsible for overseeing compliance in the good manufacturing practices as it relates to their facility standards and all aspects of their supplement manufacturing and distributing practices. The day to day activities include, training, quality checks, stability studies, label review, FDA food inspection compliance, CAPA investigations, which are integral in the Quality & Food Safety System. The candidate will also have experience with Title 21, FMSA, Part 110, 111 and 117.


Essential Functions:

· Determine disposition of finished goods and release or reject as appropriate.

· Maintain, revise, and create Controlled Documents and supporting documentation as needed to cover the manufacturing process and supply chain operations

· Implement effective SOP/GMP employee training and assessment

· Identify compliance issues/risks and provide corrective and preventative actions

· Conduct and/or assist in investigations concerning operational problems, production errors, and/or problems involving customer complaints, and ensures required material reviews and disposition decisions are properly conducted.

· Perform or oversee the completion of certain job functions required by a certified Preventive Control Qualified Individual (PQCI).

· Will support the business by assessing, managing, and approving contract manufacturers and supplier sites from a Quality and Food Safety perspective.

· Support contract manufacturers and suppliers by providing technical support, troubleshooting, training, allergen assessment, HACCP/HARPC plan reviews, and environmental testing reviews as needed.

· Implement and lead continuous improvement plans for quality functions

· Develop and maintain QMS including identification and monitoring of KPIs

· Formulate and administer policies/SOPs relating to quality assurance/control and overall QMS

· Manage, review, and approve QA/QC specifications for all finished goods.

· Ensure the finished product testing requirements are carried out for every order.

· Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards.

· Manage the Supplier Management Program ensuring appropriate Onboarding and Qualification of new suppliers and management of existing approved suppliers.

· Manage Canadian registrations and approvals of Products

· Manage Amazon product compliance

· Support Warehouse with Quality oversight in areas of receiving, storage, and shipping of food and dietary supplement products

Job Requirements and Qualifications

· Experience as a Quality Manager in a dietary supplement and or food manufacturing industry

· Previous experience with FDA inspections

· Supplier and Contract manufacturer management and auditing experience

· Ability to learn new techniques, keep accurate records, follow instructions and comply with policies is required

· Comfortable with meeting cGMPs and latest regulatory trends is required.

· Ability to manage multiple projects and initiatives on tight deadlines

· Demonstrate good interpersonal skills is required

· Must have excellent decision-making ability and deep understanding of the responsibilities with this position

· Capable of working both independently and as a team member is required

· Strong written, verbal, and interpersonal communication skills

· Experience with Canadian and Indian product registration is preferred

· Microsoft Office skills-Word, Excel, PowerPoint and Outlook

· Preventative Controls Qualitied Individual (PCQI) Preferred

· Excellent knowledge of GMPs, Sanitation, Allergens, FSMA, HACCP/HARPC, and Food Safety prerequisite programs

Education/Experience:

· Degree in a scientific discipline (Chemistry, Engineering, Physics, Biology)

· Minimum of 5 years industry experience in cGMP environment, including a leadership role in QA/QC or compliance

· Experience with domestic and international regulatory agencies

· Robust knowledge of Title 21 of the Code of Federal Regulations including experience with Part 110, 111 and 117 of Title 21 including FMSA

· PCQI or HACCP certification preferred

· Knowledge of cGMP and CGLP requirements for vitamin supplements and wellness products as well as food industry.

· Superior knowledge of FSMA requirements.

· Auditing experience preferred
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Job Details
Managed by Jobot Pro
Location
Irving, TX
Job Type
Permanent
Compensation
$110,000 - $140,000