Quality Assurance Supervisor, Day Shift

Quality Assurance Supervisor, Day Shift

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Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Sr. Manager Plant Quality

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

The Quality Assurance Supervisor is responsible for providing leadership and guidance on compliance and Good Manufacturing Practices (GMPs) that pertains to the packaging and manufacturing operations, to meet company standards and Regulatory Health Authority requirements.  The position is also responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.  Quality Assurance support areas include but are not limited to Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Walkthroughs, and In-Process Testing/AQL.  The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. 

Key Responsibilities

Quality Assurance Focus

• Provides leadership to Plant Quality-Operations team members.

• Provides leadership support to all shop floor activities including communication of quality events to management.

• Develops, performs or supports activities related to In-Process Testing, AQL’s, and/or Investigational Protocol Execution.

• Provides support to Investigations and/or CAPA. 

• Evaluate production events assuring that all appropriate actions were conducted and that appropriate batch record documentation is completed, as applicable.

• Provide approval to manufacturing and packaging operations to begin production activities. 

• Conduct in-process cGMP walk-throughs of manufacturing and packaging operations. 

• Approve master batch and packaging records assuring compliance to company standards. 

• Approve SOPs for the Fort Washington site. 

• Approve manufacturing or Technical Operations protocols for product or process changes at the Fort Washington facility.

• Performs or supports activities related to Packaging or Manufacturing Area Clearance Verifications

• May perform or support activities related to Master Batch Record creation/approval and Batch Record Issuance

• May perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Approval & Disposition.  Responsibility includes performing transactions in the following electronic systems - SAP, LIMS, and MES. 

• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s) and Work Instructions (WI’s).

• Provides support to Consumer Complaint investigations, as needed.

• Participates and provides Quality Assurance support to Change Controls, Equipment Qualifications such as Packaging Line Trials, and Validation activities.

• Provides support to Plant Maintenance for calibration system verification in SAP, as needed.

• Provide QA support to various project teams, as needed.

• Provide support to Regulatory Inspections and Internal Audits.

• Actively supports Site metrics, compliance improvement and training initiatives.

• Provide QA support to FMEAs, Green Belt or Black Belt projects.

• Participate in core Teams for both Manufacturing and Packaging operations to identify daily challenges on compliance and housekeeping opportunities that affect the quality of the product

 People & Organization Focus

• In conjunction with the Sr. Manager, Plant Quality, performance management and development of direct reports, including training, coaching and mentoring, goal setting and performance evaluation

• Have ongoing communications with staff regarding their performance

• Ensure team members are fulfilling responsibilities on time and partnering well with internal/external customers of the Plant Quality group

• Be aware of challenges faced by staff and opportunities to coach team members.  Identify areas of growth for each team member and work with management to provide appropriate feedback to staff.

• Team with management to meet recruitment needs of department

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Engineering, Science, or a related field.

• Minimum 6 years of progressive experience in quality assurance or related roles.

• Demonstrated leadership – possesses the ability to lead a team

• Strong Organizational Skills

• Strong Communication/Interpersonal and Facilitation Skills (verbal, written, presentation)

• Problem Solving/Investigation Experience

• Expertise in Handling Multiple Priorities

• Knowledge of cGMP requirements and the ability to interpret regulations

Desired Qualifications

• Advanced analytical and problem-solving abilities to interpret complex data and drive strategic quality initiatives.

• Exceptional problem-solving skills with a track record of implementing innovative solutions

• Proficiency in computer applications including MS Word, Excel, PowerPoint, and quality management software.

• Demonstrated capability to operate independently and lead cross-functional teams without direct authority.

• Strategic mindset with the ability to balance short-term operational demands and long-term quality objectives.

• Exceptional presentation and reporting skills to effectively convey quality findings and recommendations to senior leadership.

• Resilience and adaptability to lead through ambiguity, conflict, and complex organizational challenges.

• Strong interpersonal and communication abilities to effectively lead diverse teams and collaborate with multiple stakeholders.

• Demonstrated capacity to drive continuous improvement initiatives within fast-paced, high-stakes environments.

• Commitment to fostering an inclusive and empowering workplace culture that encourages creativity and accountability.

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それは何ですか

$90,100.00 - $127,200.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

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