BATCH RECORD REVIEWER
Allentown, PA 18104
BATCH RECORD REVIEWER
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. Responsible for participating in internal, external and regulatory audits at the discretion of senior management. Position is final review and ultimate release for product distribution.
The impact of review process could expose the company to criticism from customers.
- Excellent written and verbal communication skills.
- Internal: Constant contact with upper Management regarding quality issues and providing documentation.
- External: Occasional contact with customer representatives related to documentation.
-Ongoing contact with internal Operations and upper Management.
-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.
Must be proficient in Microsoft Office Suite and QAD.
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.
-Sitting for long periods of time
-Required to stand, walk, and reach with hands and arms.
-Must occasionally life and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
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.
- General knowledge of quality control/assurance.
- General knowledge of DEA regulations.
- General knowledge of EMEA.
- Excellent detail skills as they apply to documentation review and compliance.
- Good written and oral communication skills
- Good organizational and planning skills
- Excellent interpersonal skills.
Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry. This includes an understanding of statistical sampling plans.