17 days old

QA Associate Manager - OTC Products

Kelly Services
Ivyland, PA 18974
**Associate Quality Assurance Manager/Director**

Ivyland, PA

Direct Hire/Salaried


+ Manages, Plans, develops, and maintains the Quality Assurance/Quality Control department, including involvement with Operations, and purchasing in matters concerning Quality control inspection, equipment qualification, process validation, and documentation.

+ Ensures that products released meet the desired quality specifications and attributes per customer requirements, i.e. packaging specification.

+ Assures all corporate standards; Code of Federal Regulations, cGMPs, and other standards and regulations are met as applicable.

+ The Quality Assurance Manager performs quality assurance functions as required to meet the needs of the quality management system and act as a liaison between departments to ensure the quality of products shipped from the facility meets customer requirements based on the customers specification.

+ The QA Manager assists in writing inspection documentation utilized to evaluate and identify defective products.

+ The QA Manager assists in maintaining, managing, and controls the distribution of batch records and document control.

+ This position works to improve processes, using data collected, and apply problem-solving techniques.

+ Participates in the development, planning, implementation, and maintenance of related methods and technology and applications that meet the required standards for commercial and pharmaceutical packaging.

+ Supports the design and development of new product packaging and participates in process design and development activities, supports new product start up meetings. Responsible for preparing the quality plans and determining routine quality control of products.

+ Interacts with Product Development and Operations to assure statistically based quality systems intended for use in the quantitative measurement of process variability as applicable.

+ Develops and maintains systems to track and report trends in key quality system indicators as applicable. (Metrics and Quality Control Charts).

+ Works with the management team on planning, developing and achieving the companys Quality Assurance Department goals and objectives.

+ Works with the management team in establishing, implementing and maintaining the integrity of the Quality Management System.

+ Works with the management team in creating QA in-process control documentation that is accurate, correct and aligns with the customers specifications and expectations.

+ Responsible for standardizing and optimizing product inspection procedures and supervise the product inspection activities, as applicable.

+ Maintains the accuracy of the Standard Operating Procedures Manual by ensuring the latest version of policies, procedures and work instructions are present.

+ Responsible for reviewing batch records for accuracy and completeness.

+ Maintains, manages and controls the distribution of batch records.

+ Ensures the appropriate records are sent to the customer in a timely manner.

+ Ensures required samples collected during production are sent to customers, as applicable.

+ Assists in conducting audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

+ Participates and assists in Facility and supplier audits, as applicable in customer, regulatory and third party audits as needed.

+ Assists in enforcing companys plant policies and cGMPs.

+ Trains QA staff and other departments on quality assurance and manufacturing policies and procedures as needed.

+ Develops leadership capabilities and skills for subordinates in the quality organization.?

+ Reviews/approves product and process change controls.

+ Manages and improves current Quality Systems to include the following: CAPA, Change Control.? Deviations, Audits, Annual Product Reporting and ensure that procedures (SOPS and operating instructions) as well as Master Batch Records are available, and administers the documentation program for review and approval.?

+ Applies problem solving techniques (e.g. root cause analysis) to resolve non-conformance and customer complaints. Assess and reports on levels of compliance and other areas of potential risk to Company business.

+ Investigates customer/?consumer complaints and in-house generated excursions (process, technical, etc.?).? Establishes probable cause, to minimize potential impact, and/?or reveal opportunities for improvement in operations (production, laboratories, etc.?)?.

+ Develops and maintains relationships with Customers for current and future products.

+ Shares responsibility with the management team for preparation of departmental training plans and training of personnel in inspection techniques and relevant Quality Control procedures, as applicable.

+ Other duties as assigned.

**Qualifications, Knowledge, and Skills Required:**

+ Bachelors Degree in Biological/Chemistry Sciences or Business/Organizational Management.

+ Knowledge of FDA OTC drug manufacturing principles (minimum 1 year experience)

+ Knowledge of QA methodologies and implementation within a manufacturing environment (minimum 1 year experience)

+ SAP experience preferred

+ Strong relationship building skills.

+ Excellent written and oral communication skills.

+ Strong Microsoft Office computer skills.

+ Excellent analytical skills and detail oriented

+ Ability to operate effectively and be flexible in a dynamic environment.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-09-07 Expires: 2020-10-08

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QA Associate Manager - OTC Products

Kelly Services
Ivyland, PA 18974

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