Overview
QA – Batch Record Reviewer Jobs in Moonachie, NJ at June Jacobs Labs
SUMMARY
Responsibilities include review of batching and line documentation related to contract manufacturing of non-OTC and OTC formulas. 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.
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 bulk manufacturing and filling operations after completion of reconciliation and testing.
Responsible for critical review 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 manufacturing, 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 participating in internal, customer, and regulatory audits at the discretion of senior management.
Responsible for training of designated peers as a replacement. This is completed at management’s request.
Responsible for performing APR (Annual Product Review) for all OTC products.
Responsible for assisting with the creation of documentation for Health Canada (CoA,
CoM , Fill and Assembly Specifications) market release.
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.
– General knowledge of quality control/assurance.
– Excellent time management skills
– 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.
MATHEMATICAL SKILLS:
Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry. This includes an understanding of statistical sampling plans.
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: Quality Department, Material Management and Operations Department employees for information on quality documentation issues and cGMP issues.
– External: Occasional contact with customer representatives related to documentation.
COMPUTER SKILLS:
Must be proficient in Microsoft Office Suite and Batch Master
PHYSICAL DEMANDS:
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.
Job Type: Full-time
Pay: From $20.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible schedule
- Health insurance
- Health savings account
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
Work Location: In person
Title: QA – Batch Record Reviewer
Company: June Jacobs Labs
Location: Moonachie, NJ
Category:
