Quality Assurance Supervisor I

The Quality Assurance Supervisor I is responsible for the organization administration and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the daytoday operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. This includes delivering high levels of customer service ensure quality of product and services comply with all regulatory requirements achieve desired financial performance including cost reductions and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new intermediate and finished products. Responsible for GMP compliance manufacturing quality product control and release system and quality planning for the manufacturing areas that it supports.

Responsibilities

• Responsible for leading a high performing team and prioritizing presence with the team.
• Leads a team in the Quality function & is responsible for hiring setting performance expectations driving team engagement providing continuous & ontime performance feedback developing staff assisting team in problemsolving & handling of employee matters. Ensures that the department has the appropriate talent & level of performance to meet business objectives. Monitors administration of training identifies training needs & development of team.
• Provide Quality support on the manufacturing shop floor
• Responsible for supporting Operations efforts in meeting established production schedule
• Partner with Operations employees to document exception documents including reinspection and resolve other outstanding plant quality/compliance issues
• Propose changes update author and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
• Investigate QC hold quarantine and reject for materials not meeting standards ensure the initiation of exception documentation and oversee the implementation of any corrective action
• Responsible for the review and approval of Procedures and Change Requests
• Assist/serve/provide feedback on continuous improvement initiatives/teams
• Reviews and releases batch records.
  May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.

Qualifications :

• Bachelors degree in sciences or engineering or equivalent experience
• 2 years of experience in a manufacturing production environment.
• Experience in regulated pharmaceutical industry is preferred.
• Thorough knowledge of Quality Assurance operations including safety application of FDA and GMP regulations.
• Direct manufacturing and regulatory interface experience is preferred.
• Effective problemsolving decisionmaking teamwork influence negotiation and conflict resolution skills required
• Ability to work crossfunctionally and coordinate work both within the department and with other departments.
• Ability to identify communicate and follow through to completion and assist in the development of necessary corrective action plans to resolve problems with supervision
• Demonstrated strong leadership skills and ability to foster an inclusive environment

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Work :

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