Manager, Quality Assurance

SUMMARY

Responsibilities include supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports.  Responsible for contact with QA representatives from each customer regarding quality issues related to documentation, inspection and packaging process.  Participate in audits by customers and other regulatory agencies.  Responsible for ongoing contact with internal Operations, Sales, Engineering and Quality Department employees concerning compliance with customer requirements as well as cGMP’s specific to the site.

Scope of the position is focused on the Allentown facilities. The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The all-inclusive list of responsibilities may be distributed to multiple supervisors/managers.  Other duties may also be assigned.

• Supervise quality functions including 3 shifts of employees, label production, in-process inspections and finished product inspections.

• Participate in internal, regulatory and customer audits and customer visits at the discretion of management.

• Follow-up on all customer audits specific to the site including assisting in the audit response and monitoring commitments specific to the related areas in quality.

• Investigate deviations related to procedures, policies, specifications or protocols.

• Participate in regulatory inspections of the local site at the discretion of senior management.

• Investigate consumer complaints related to packaging that are received from customers specific to related areas.

• Review and revise or establish SOPs on a designated basis to ensure accuracy and compliance for the organization. 

• Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management.

• Oversee and document the training of floor staff to ensure job functions are clear.

• Management of the Label Room and staff for the creation and printing of labels and Batch Record preparation/printing prior to production.

• Responsible for the completion of Environmental Samples in compliance the Environmental Monitoring program

• Ensuring that quality equipment is in compliance with calibration program.

• Assist with the development of Master Packaging Records to compliance with accurate and traceable packaging processes.

• Review and Approval of Change Controls, Temporary Change Controls, Bill of Materials for accuracy and compliance to requirement.

• Review and approval of Floor related Deviated Material Reports

SUPERVISORY RESPONSIBILITIES:

Direct supervision of quality assurance floor inspectors at the local sites.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and problem resolution.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in Science (BS/BA) from a four-year college or university preferred; or five (5) to ten (10) years-related experience and or training; or equivalent combination of education and experience.

- Knowledge of FDA regulations including cGMP’s and current industry practice

   required.       

- Thorough knowledge of quality control/assurance and/or operations required.

- Knowledge of DEA regulations desired.

- Broad knowledge of current pharmaceutical industry including packaging practices

   desired.

- Above average written and oral communication skills required.

- Above average organizational and planning skills required.

MATHEMATICAL SKILLS:

Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry.  This includes evaluation of statistical sampling plans.

LANGUAGE SKILLS:

Ability to read and interpret common scientific data.  Ability to respond to common inquiries or complaints from customers, Ability to direct and respond to inquiries from peers and subordinates.  Ability to effectively present information to the following groups:

- Internal: Frequent contact with Quality Department, Project Managers, Account Planners and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer quality issues and cGMP issues.

- External: Frequent contact with customer representatives conducting audits, planning new product introductions, addressing technical agreements and problem-solving quality issues specific to the site.

REASONING ABILITY:

Ongoing contact with internal Operations and Quality Department employees.  Frequent contact with customer representatives concerning compliance with specifications, as well as cGMP’s. Customer agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. A thorough internal audit and follow-up program is necessary to prepare for customer audits and regulatory inspections. Good organizational skills are necessary. Good mental skills for analysis and problem solving are needed.

CERTIFICATES, LICENSES, REGISTRATIONS:

Must be proficient in Microsoft Office Suite.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently is required to sit.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The employee must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor.  The working environment is clean and not normally subject to hazardous environment or conditions.

Approximately 5-10 percent auto travel between sites.

Travel to customers on an as needed basis.