Batch Record Reviewer (2nd Shift)

SUMMARY

Responsibilities include review of line documentation related to contract packaging.  Will follow up on customer inquiries as they relate to same documentation and compliance issue.  Complete final review and release for product distribution. The impact of review process directly impacts company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to record review.  Other duties may also be assigned.

• Responsible for review of documentation related to primary, secondary, and clinical packaging after completion of reconciliation.

• Responsible for critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.

• Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.

• Responsible for final release of work in-process or finished product.

• Responsible for reviewing and maintaining the QAD Item Master Maintenance and Router Maintenance.
• Responsible for logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.

• Responsible for maintaining and filing of documentation related to packaging in current appropriate status locations.

• Responsible for entering lot specific information into the Quality Dashboard (Access Database).

• Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.

• Other responsibilities as required.

SUPERVISORY RESPONSIBILITIES: None

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duties and responsibilities 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:

High School Degree is required.  One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.

- General knowledge of FDA regulations related to cGMPs required.

- General knowledge of cGDPs required.

- General knowledge of quality control/assurance required.

- General knowledge of DEA regulations preferred.

- Excellent detail skills as they apply to documentation review and compliance required.

- Good written and oral communication skills required.

- Good organizational and planning skills required.

- Excellent interpersonal skills required.

REQUIREMENTS:

Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals. Basic math skills (addition, subtraction, multiplication and division) are required.

LANGUAGE SKILLS:

Ability to respond to common inquiries or complaints from customers. Ability to respond to inquiries from peers and superiors.  Ability to effectively present information to the following groups:

- Internal: Frequent contact with Quality Department, Project Managers, New Business     Development, Material Management and Operations Department employees for information on quality   documentation issues and cGMP issues.

- External: Occasional contact with customer representatives related to documentation.

REASONING ABILITY:

Ongoing contact with internal Sharp Operations, Project Managers, New Business Development, Material Management and Quality Department employees.  Frequent contact with customer representatives concerning documentation issues, as well as cGMP’s.  A thorough understanding or each aspect of the job is required. Good organizational skills are necessary. Good reasoning skills for analysis and problem solving are needed.

COMPUTER SKILLS:

Must be proficient in Microsoft Office Suite, Adobe Acrobat, and QAD. Experience with Pilgrim SmartSolve system desired.

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.  While performing the duties of this job, the employee is regularly required to use hands, speak and listen.  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 20 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.